# K041635: G5 I HBA1C Test, G5 II HBA1C Test

- Pathway: 510(k) (Traditional)
- Applicant: Provalis Diagnostics, Ltd.
- Decided: Aug 16, 2004 after 61 days
- Product code: LCP (Assay, Glycosylated Hemoglobin)
- Device class: 2
- Regulation: 21 CFR 864.7470
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K952720 (1995). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952720: Aalto Scientific LTD. Glycated Hemoglobin Control Levels I & II, Aalto Scientific, Ltd. (1995). Our reading of the summary gave “K952720.” beside “510(k)”; FDA’s K952720 is the only number that fits it and carries the summary’s name for the device. Summary page 8.
- (no number) Glycosal II HbA1c Test: named in the summary without a submission number

## Most influential descendants
- K081269: Avie A1C Test System (2009), 0 descendants of its own

## Recalls of this device
- Sep 7, 2010 · Not classified · Z-0109-2011: Test Cartridges may leak and have the potential to generate error messages and biased inaccurate results.
- Jul 26, 2010 · Not classified · Z-0122-2011: Inaccurate results with high bias-- Inaccurate results may be read by the machine, creating the risk for untreated hypoglycemia at elevated altitudes.
- Aug 3, 2006 · Not classified · Z-2460-2008: Cholestech Corp. was notified by the foreign manufacturer of the A1C test cartridge that stability data indicated that the product would not meet performance claims through the end of its shelf life.
- May 20, 2005 · Not classified · Z-0171-06: Provalis Diagnostics discovered, following its internal stability testing program (mid-point batch testing), that occasional low values were being found across multiple lots of in2it HbA1C Test Cartri

## Indications for use
The G5 II HbAlc Test System is intended for testing blood taken from a fingerprick. G5 II HbAl c Test System shows how good glucose control has been over a two to three month period. The G5 II HbAlc Test System consists of the HbAlc test cartridge, the G5 Instrument, the G5 System Check Cartridge and the 05 HbAlc Quality Controls. The G5 II HbAlc Test System is intended for prescription home use. The G5 I HbAlc Test System is an affinity chromatography method and is intended for the in vitro quantitative determination of HbAl c in capillary blood taken from a fingerprick or whole blood in EDTA. G5 I HbAl c Test System is indicated for monitoring the time averaged blood glucose levels of known diabetics, for professional use as an indicator of overall Glycaemic control. The G5 I HbAlc Test System consists of the HbAlc test cartridge, the G5 Instrument, the G5 System Check Cartridge and the G5 HbAlc Quality Controls. The 05 I HbAlc Test System is intended for use in a physicians/ doctors office.

Source page: https://510kreport.com/device/K041635
Methodology: https://510kreport.com/methodology