# K941287: Liquid Alt (SGPT) Reagent Set

- Pathway: 510(k) (Traditional)
- Applicant: Pointe Scientific, Inc.,
- Decided: May 3, 1994 after 47 days
- Product code: CKA (Nadh Oxidation/Nad Reduction, Alt/Sgpt)
- Device class: 1
- Regulation: 21 CFR 862.1030
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- Dec 14, 2007 · Not classified · Z-1113-2008: Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms.
- Dec 14, 2007 · Not classified · Z-1111-2008: Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms.
- Dec 14, 2007 · Not classified · Z-1116-2008: Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms.
- Dec 14, 2007 · Not classified · Z-1117-2008: Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms.
- Dec 14, 2007 · Not classified · Z-1114-2008: Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms.
- Dec 14, 2007 · Not classified · Z-1110-2008: Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms.
- Dec 14, 2007 · Not classified · Z-1115-2008: Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms.
- Dec 14, 2007 · Not classified · Z-1112-2008: Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms.

Source page: https://510kreport.com/device/K941287
Methodology: https://510kreport.com/methodology