# K060650: Vitros Chemistry Products D%A1C Reagent Kit, Model 680 2314; Vitros Chemistry Products Calibrator Kit 18, Model 680 1702

- Pathway: 510(k) (Special)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: Apr 6, 2006 after 24 days
- Product code: LCP (Assay, Glycosylated Hemoglobin)
- Device class: 2
- Regulation: 21 CFR 864.7470
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K000534 (2000). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041764: The Vitros 5,1 FS Chemistry System, Ortho-Clinical Diagnostics (2004) Summary page 1.
- K052645: Vitros Chemistry Products Calibrator Kit 28, Ref 680 2323; Vitros Chemistry Products FS Calibrator 1, Ref 6801873;, Ortho-Clinical Diagnostics (2005) Summary page 1.

## Indications for use
For in vitro diagnostic use only. VITROS Chemistry Products d%Alc Reagent Kit is used to determine the percent glycated hemoglobin (%AI c) in human whole blood by quantitative measurement of hemoglobin (Hb) and hemoglobin Alc (HbAlc). Measurements of percentage Alc are effective in monitoring long-term glycemic control in individuals with diabetes mellitus. For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 18 is used in conjunction with VITROS Chemistry Products FS Calibrator I to calibrate VITROS 5,1 FS Chemistry Systems for the calculation of percent glycated hemoglobin (%Alc). For in vitro diagnostic use only. VITROS Chemistry Products FS Calibrator I is used in conjunction with VITROS Chemistry Products Calibrator Kits 16, 17, 18, 19 and 28 to calibrate VITROS 5,1 FS Chemistry Systems.

Source page: https://510kreport.com/device/K060650
Methodology: https://510kreport.com/methodology