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All Medicus GlucoDr S BLE (AGM-513S)
Device Name:
GlucoDr S BLE
Device Model:
AGM-513S
Manufacturer:
All Medicus Co. Ltd., Room 7608, 140 Beolmal-ro, Dongan-gu, Anyang-si, Gyeonggi-do 431-804 (Room 7106, Dong-il Techno Town 7-cha, 823 Gwanyang 2 dong, Dongan-gu, Anyang-si, Gyeonggi-do 431-716), REPUBLIC of KOREA.
Measuring functions:
Blood glucose
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Finger
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Device Manual:
Click here to download the Device Manual
Description:
The All Medicus GlucoDr S BLE (AGM-513S) is an automatic blood glucose meter. The accuracy of its blood glucose measurement technology has yet to be proven to MDR requirements. Blood glucose measurements are taken from the finger. It is intended for self-measurement and home use.
Assessment:
The technology used in the All Medicus GlucoDr S BLE (AGM-513S), to measure blood glucose, has been declared as being substantially equivalent to that used in another device, according to 510(k), but this is not compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.
Recommendations:
Accuracy AssessmentRecommendationBasis
BG Medaval None Although equivalence to another device is claimed, this has not been tested to MDR requirements.
BG FDA (US) 510(k) 510(k) K170241
Device Family:
All Medicus GlucoDr Auto A (AGM-4000)F, All Medicus GlucoDr S (AGM-513S)F, All Medicus GlucoDr S BLE (AGM-513S)F, Roche Accu-Chek Advantage (V1)F, Roche Accu-Chek AvivaF
Legend: F FDA 510(k)
Validation Publications for Equivalent Devices:

Note: This is a provisional list, as equivalence according to EU Regulation 2017/745 (e.g. MEDDEV 2.7/1 rev 4) is not proven. Accordingly, these publications are not used in the assessment of star-ratings.

All Medicus GlucoDr Auto A (AGM-4000)

Jendrike N, Baumstark A, Kamecke U, Haug C, Freckmann G. ISO 15197: 2013 Evaluation of a Blood Glucose Monitoring System's Measurement Accuracy. J Diabetes Sci Technol. 2017 Nov;11(6):1275-6. Epub: 2017 Aug 29. doi: 10.1177/1932296817727550. PMID: 28849677. Available from: PMC5951056. No abstract available.

15197:2013 - Pass General population

Roche Accu-Chek Advantage (V1)

Ho HT, Yeung WK, Young BW. Evaluation of "point of care" devices in the measurement of low blood glucose in neonatal practice. Arch Dis Child Fetal Neonatal Ed. 2004 Jul;89(4):F356-359. doi: 10.1136/adc.2003.033548. PMID: 15210675. Available from: PMC1721720.

ADA:1994 - Fail Neonates (n = 57) (Note: Error < 10 %: 20.0% )

CLSI:1994 - Fail Neonates (n = 57) (Note: Error ≤ 0.83 mmol/L: 81.5% (< 95 %))

Thomas LE, Kane MP, Bakst G, Busch RS, Hamilton RA, Abelseth JM. A glucose meter accuracy and precision comparison: the FreeStyle Flash Versus the Accu-Chek Advantage, Accu-Chek Compact Plus, Ascensia Contour, and the BD Logic. Diabetes Technol Ther. 2008 Apr;10(2):102-110. doi: 10.1089/dia.2007.0244. PMID: 18260773.

Ad Hoc protocol General population

Roche Accu-Chek Aviva

Freckmann G, Baumstark A, Jendrike N, Zschornack E, Kocher S, Tshiananga J, Heister F, Haug C. System accuracy evaluation of 27 blood glucose monitoring systems according to DIN EN ISO 15197. Diabetes Technol Ther. 2010 Mar;12(3):221-31. doi: 10.1089/dia.2009.0128. PMID: 20151773.

15197:2003 - Pass General population

de Mol P, Krabbe HG, de Vries ST, Fokkert MJ, Dikkeschei BD, Rienks R, Bilo KM, Bilo HJ. Accuracy of handheld blood glucose meters at high altitude. PLoS One. 2010 Nov 12;5(11):e15485. doi: 10.1371/journal.pone.0015485. PMID: 21103399.

Ad Hoc protocol - Pass High Altitude (Note: Simulated altitude in hypobarbic chamber)

Tack C, Pohlmeier H, Behnke T, Schmid V, Grenningloh M, Forst T, Pfützner A. Accuracy evaluation of five blood glucose monitoring systems obtained from the pharmacy: a European multicenter study with 453 subjects. Diabetes Technol Ther. 2012 Apr;14(4):330-7. Epub: 2011 Dec 16. doi: 10.1089/dia.2011.0170. PMID: 22176154.

15197:2003 - Pass General population

15197:2013 - Fail General population

Baumstark A, Pleus S, Schmid C, Link M, Haug C, Freckmann G. Lot-to-lot variability of test strips and accuracy assessment of systems for self-monitoring of blood glucose according to ISO 15197. J Diabetes Sci Technol. 2012 Sep 1;6(5):1076-86. doi: 10.1177/193229681200600511. PMID: 23063033. Available from: PMC3570841.

15197:2003 - Pass General population (Note: 4 test-strip lots; all 4 within requirements)

Freckmann G, Schmid C, Baumstark A, Pleus S, Link M, Haug C. System accuracy evaluation of 43 blood glucose monitoring systems for self-monitoring of blood glucose according to DIN EN ISO 15197. J Diabetes Sci Technol. 2012 Sep 1;6(5):1060-75. PMID: 23063032. Available from: PMC3570840.

15197:2003 - Pass General population

15197:2013 - Pass General population

Pfützner A, Mitri M, Musholt PB, Sachsenheimer D, Borchert M, Yap A, Forst T. Clinical assessment of the accuracy of blood glucose measurement devices. Curr Med Res Opin. 2012 Apr;28(4):525-31. Epub: 2012 Mar 21. doi: 10.1185/03007995.2012.673479. PMID: 22435798.

15197:2003 - Pass General population

Zueger T, Schuler V, Stettler C, Diem P, Christ ER. Assessment of three frequently used blood glucose monitoring devices in clinical routine. Swiss Med Wkly. 2012 Jul 12;142:w13631. doi: 10.4414/smw.2012.13631. PMID: 22791566. eCollection 2012.

15197:2003 - Pass General population (Note: Reference device: HemoCue Glucose 201+)

Pfützner A, Schipper C, Ramljak S, Flacke F, Sieber J, Forst T, Musholt PB. Evaluation of the effects of insufficient blood volume samples on the performance of blood glucose self-test meters. J Diabetes Sci Technol. 2013 Nov 1;7(6):1522-9. doi: 10.1177/193229681300700612. PMID: 24351178. Available from: PMC3876330.

15197:2003 - Fail Using insufficient blood samples (n=31)

Halldorsdottir S, Warchal-Windham ME, Wallace JF, Pardo S, Parkes JL, Simmons DA. Accuracy evaluation of five blood glucose monitoring systems: the North American comparator trial. J Diabetes Sci Technol. 2013 Sep 1;7(5):1294-304. doi: 10.1177/193229681300700520. PMID: 24124957. Available from: PMC3876374.

Ad Hoc protocol General population

Freckmann G, Baumstark A, Schmid C, Pleus S, Link M, Haug C. Evaluation of 12 blood glucose monitoring systems for self-testing: system accuracy and measurement reproducibility. Diabetes Technol Ther. 2014 Feb;16(2):113-22. Epub: 2013 Nov 8. doi: 10.1089/dia.2013.0208. PMID: 24205978.

15197:2003 - Pass General population

15197:2013 - Pass General population

Pfützner A, Hengesbach C, Demircik F, Schipper C, Forst T, Musholt PB. Performance of blood glucose meters in compliance with current and future clinical ISO15197 accuracy criteria. Curr Med Res Opin. 2014 Feb;30(2):185-90. Epub: 2013 Nov 6. doi: 10.1185/03007995.2013.858617. PMID: 24156775.

15197:2003 - Pass General population

15197:2013 - Pass General population

Pleus S, Schmid C, Link M, Baumstark A, Haug C, Stolberg E, Freckmann G. Accuracy assessment of two novel systems for self-monitoring of blood glucose following ISO 15197:2013. J Diabetes Sci Technol. 2014 Jul;8(4):906-8. Epub: 2015 Ma5 25. doi: 10.1177/1932296814536030. PMID: 24876447. Available from: PMC4764206.

15197:2013 - Pass General population

Link M, Schmid C, Pleus S, Baumstark A, Rittmeyer D, Haug C, Freckmann G. System Accuracy Evaluation of Four Systems for Self-Monitoring of Blood Glucose Following ISO 15197 Using a Glucose Oxidase and a Hexokinase-Based Comparison Method. J Diabetes Sci Technol. 2015 Apr 14;9(5):1041-50. doi: 10.1177/1932296815580161. PMID: 25872967. Available from: PMC4667333.

15197:2003 - Pass General population

15197:2013 - Pass General population (Note: HK Comparison (Manufacturer))

15197:2013 - Pass General population (Note: GOx Comparison (Alternative))

Sølvik UØ, Risa M, Jacobsen CE, Monsen G, Sandberg S. Performance of 10 Systems for Self-Monitoring of Blood Glucose by Trained Healthcare Professionals and in the Hands of the Users. Clin Chem. 2015 May;61(5):772-4. Epub: 2015 Mar 3. doi: 10.1373/clinchem.2014.236760. PMID: 25737533. Available from: clinchem.aaccjnls.org.

15197:2013 - Pass General population (Note: BLS-recorded measurements)

FDA:2016H - Pass General population (Note: BLS-recorded measurements)

15197:2013 - Fail General population (Note: Subject-recorded measurements)

FDA:2016H - Fail General population (Note: Subject-recorded measurements)

15197:2003 - Pass General population

SKUP Evaluations 2005/44, 2013/98

Freckmann G, Pleus S, Link M, Baumstark A, Schmid C, Högel J, Haug C. Accuracy Evaluation of Four Blood Glucose Monitoring Systems in Unaltered Blood Samples in the Low Glycemic Range and Blood Samples in the Concentration Range Defined by ISO 15197. Diabetes Technol Ther. 2015 Sep;17(9):625-34. Epub: 2015 May 19. doi: 10.1089/dia.2015.0043. PMID: 26062008.

15197:2013 General population (Note: Results not in Abstract)

Sutheran HL, Reynolds T. Technical and clinical accuracy of three blood glucose meters: clinical impact assessment using error grid analysis and insulin sliding scales. J Clin Pathol. 2016 Oct;69(10):899-905. Epub: 2016 Feb 5. doi: 10.1136/jclinpath-2015-203339. PMID: 26850631.

15197:2003 General population

From the absract, it appears that an evaluation of the Abbott FreeStyle Lite, the Roche Accu-Chek Aviva and an unnamed third device was performed. Neither the protocol used nor the results are clear from the abstract.

Mancini A, Esposto G, Manfrini S, Rilli S, Tinti G, Carta G, Petrolati L, Vidali M, Barocci S. A Real-World Setting Study: Which Glucose Meter Could Be the Best for POCT Use? An Easy and Applicable Protocol During the Hospital Routine. J Diabetes Sci Technol. 2018 Sep;12(5):1053-1060. Epub: 2018 May 22. doi: 10.1177/1932296818774077. PMID: 29783898. Available from: PMC6134620.

SIBioC:2015 General population

Note: Results from this paper are not presented due to a number of inaccuracies.

Dunseath GJ, Bright D, Luzio SD. Comparative Accuracy Evaluation of a Blood Glucose Meter With Novel Hematocrit Correction Technology, With Three Currently Used Commercially Available Blood Glucose Monitoring Systems. J Diabetes Sci Technol. 2019 May;13(3):568-574. Epub: 2019 Jan 9. doi: 10.1177/1932296818821389. PMID: 30623673. Available from: PMC6501526.

15197:2013 - Pass General population (Note: Modified protocol: Single batch of test strips only. Some hematocrit associated bias noted.)

SKUP. Report from the evaluation SKUP/2005/44: Accu-Chek Aviva (Roche Diagnostics), a system for blood glucose measurement. Bergen, Norway: SKUP; 2005. 40 p. Available from: skup.org.

15197:2003 - Pass General population (Note: BLS-recorded measurements)

15197:2003 - Pass General population (Note: Subject-recorded measurements)

Results counted in Sølvik et al. 2015.

SKUP. Report from the evaluation SKUP/2013/98: Accu-Chek Aviva (Roche Diagnostics), a system for blood glucose measurement. Bergen, Norway: SKUP; 2013. 38 p. Available from: skup.org.

15197:2003 - Pass General population

Results counted in Sølvik et al. 2015.

SKUP. Report from the evaluation SKUP/2014/105: Accu-Chek Aviva (Roche Diagnostics), a system for blood glucose measurement. Bergen, Norway: SKUP; 2014. 55 p. Available from: skup.org.

15197:2013 - Pass General population (Note: BLS-recorded measurements)

15197:2013 - Pass General population (Note: Subject-recorded measurements)

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