# K041764: The Vitros 5,1 FS Chemistry System

- Pathway: 510(k) (Traditional)
- Applicant: Ortho-Clinical Diagnostics
- Decided: Sep 9, 2004 after 71 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: 1 generation back to K904768 (1990). 2 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972265: A1C 2.2 Plus - Automated Glycohemoglobin Analyzer, Tosoh Medics, Inc. (1997) Summary page 3.
- K904768: Kodatrol I and II Control and Diluent Set, Eastman Kodak Company (1990) Summary page 4.

## Most influential descendants
- K081895: Advia Chemistry Hemoglobin A1C, Advia Chemistry A1C Calibrators (2009), 1 descendant of its own
- K142595: VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS Chemistry Products %A1c Performance Verifiers I and II (2015), 0 descendants of its own
- K110934: Advia Chemistry Hemoglobin A1C_3 (A1C_3) Automated Pretreatment Assay (2011), 0 descendants of its own
- 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 %Alc Reagent Kit is used to calculate percent glycated hemoglobin (%Ale) in pretreated human whole blood by quantitative measurement of hemoglobin (Hb) and hemoglobin Ale (HbAlc). Measurements of percentage Al c are effective in monitoring long-term glucose 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 (%Ale). For in vitro diagnostic use only. VITROS Chemistry Products %Alc Performance Verifiers are assayed controls used to monitor performance of %Alc Reagent Kit on VITROS 5,1 FS Chemistry Systems.

Source page: https://510kreport.com/device/K041764
Methodology: https://510kreport.com/methodology