# K001679: Vitros Chemistry Products Ast Slide and Chemistry Products Calibrator Kit 3

- Pathway: 510(k) (Special)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: Jun 28, 2000 after 27 days
- Product code: CIT (Nadh Oxidation/Nad Reduction, Ast/Sgot)
- Device class: 2
- Regulation: 21 CFR 862.1100
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K161140: VITROS Chemistry Products Calibrator Kit 3 (2016), 0 descendants of its own

## Recalls of this device
- Jun 12, 2013 · Class II · Z-0299-2014: Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.
- Feb 2, 2012 · Not classified · Z-1277-2012: Ortho Clinical Diagnostics received complaints of lower than expected results (< 6 U/L) for samples that were known to be outside of the measuring (reportable) range (> 1000 U/L) when using Calibratio

Source page: https://510kreport.com/device/K001679
Methodology: https://510kreport.com/methodology