# K002199: Modification to Liquid Glucose (Hexokinase) Reagent Set

- Pathway: 510(k) (Traditional)
- Applicant: Pointe Scientific, Inc.,
- Decided: Nov 20, 2000 after 123 days
- Product code: CFR (Hexokinase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 14 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K072018: BS-200 Chemistry Analyzer, Mode BS-200 (2008), 3 descendants of its own
- K112377: BS-400 Chemistry Analyzer, CLC 720 Chemistry Analyzer (2012), 1 descendant of its own
- K160370: BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistry Analyzer, ABS800 Chemistry Analyzer (2016), 0 descendants of its own
- K140690: BS-480 Chemistry Analyzer, BS-490 Chemistry Analyzer, CLC720I Chemistry Analyzer (2014), 0 descendants of its own

## Recalls of this device
- Sep 10, 2008 · Not classified · Z-0221-2009: The inability of the product to maintain stated performance specifications through the stated shelf life.
- Sep 10, 2008 · Not classified · Z-0223-2009: The inability of the product to maintain stated performance specifications through the stated shelf life.
- Sep 10, 2008 · Not classified · Z-0222-2009: The inability of the product to maintain stated performance specifications through the stated shelf life.
- Sep 10, 2008 · Not classified · Z-0219-2009: The inability of the product to maintain stated performance specifications through the stated shelf life.
- Sep 10, 2008 · Not classified · Z-0220-2009: The inability of the product to maintain stated performance specifications through the stated shelf life.
- Sep 10, 2008 · Not classified · Z-0224-2009: The inability of the product to maintain stated performance specifications through the stated shelf life.
- Jun 7, 2006 · Not classified · Z-1329-06: Product does not meet performance specifications through its labeled expiration period.
- Jun 7, 2006 · Not classified · Z-1328-06: Product does not meet performance specifications through its labeled expiration period.
- Jun 7, 2006 · Not classified · Z-1327-06: Product does not meet performance specifications through its labeled expiration period.
- Jun 7, 2006 · Not classified · Z-1326-06: Product does not meet performance specifications through its labeled expiration period.
- Jun 7, 2006 · Not classified · Z-1330-06: Product does not meet performance specifications through its labeled expiration period.
- Jun 7, 2006 · Not classified · Z-1333-06: Product does not meet performance specifications through its labeled expiration period.
- Jun 7, 2006 · Not classified · Z-1332-06: Product does not meet performance specifications through its labeled expiration period.
- Jun 7, 2006 · Not classified · Z-1331-06: Product does not meet performance specifications through its labeled expiration period.

Source page: https://510kreport.com/device/K002199
Methodology: https://510kreport.com/methodology