# K052645: Vitros Chemistry Products Calibrator Kit 28, Ref 680 2323; Vitros Chemistry Products FS Calibrator 1, Ref 6801873;

- Pathway: 510(k) (Traditional)
- Applicant: Ortho-Clinical Diagnostics
- Decided: Dec 14, 2005 after 79 days
- Product code: GTQ (Antistreptolysin - Titer/Streptolysin O Reagent)
- Device class: 1
- Regulation: 21 CFR 866.3720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K000534 (2000). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041863: Vitros Chemistry Products RF Reagent, Vitros Chemistry Products Calibrator Kit 16, Vitros Chemistry Products FS, Ortho-Clinical Diagnostics, Inc. (2004) Summary page 1.

## Most influential descendants
- K060650: Vitros Chemistry Products D%A1C Reagent Kit, Model 680 2314; Vitros Chemistry Products Calibrator Kit 18, Model 680 1702 (2006), 0 descendants of its own

## Indications for use
For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 28 is used in conjunction with VITROS Chemistry Products FS Calibrator 1 to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of antistreptolysin 0 (ASO). For in vitro diagnostic use only. VITROS Chemistry Products FS Calibrator 1 is used in conjunction with VITROS Chemistry Products Calibrator Kits 16, 17, 18, 19, and 28 to calibrate VITROS 5,1 FS Chemistry Systems. For in vitro diagnostic use only. VITROS Chemistry Products ASO/RF Performance Verifiers are assayed controls used to monitor the performance of VITROS ASO and RF Reagent on VITROS 5,1 FS Chemistry Systems.

Source page: https://510kreport.com/device/K052645
Methodology: https://510kreport.com/methodology