# K052819: Vitros Chemistry Products Aat Reagent, Calibrator Kit 99 and Aat Performance Verifiers I, II and Iii

- Pathway: 510(k) (Traditional)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: Dec 23, 2005 after 80 days
- Product code: DEM (Alpha-1-Antitrypsin, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5130
- 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 K904768 (1990). 12 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964766: Immage Immunochemistry System Alpha-1-Antitrypsin (Aat), Beckman Instruments, Inc. (1997) Summary page 3.
- K973932: Beckman Calibrator 2 (CAL2), Beckman Instruments, Inc. (1997) Summary page 3.
- K042477: Vitros Chemistry Products Trfrn Reahent; Vitros Chemistry Products Calibrator Kit 20; Vitros Chemistry Products Protein, Ortho-Clinical Diagnostics, Inc. (2004) Summary page 3.

## Most influential descendants
- K061588: Vitros Chemistry Products Hcy Reagent, Vitros Chemistry Products Calibrator Kit 27, Hcy Performance Verifiers (2006), 1 descendant of its own
- K123930: Vitros Chemistry Products Hcy 2 Reagent, Calibrator Kit 27, Hcy 2 Performance Verifiers I, II and Iii (2013), 0 descendants of its own
- K060940: Vitros Chemistry Products Calibrator Kit 99, Vitros Chemistry Products Aat/HPT Performance Verifier I, II, and Iii (2006), 0 descendants of its own

## Indications for use
For in vitro diagnostic use only. VITROS Chemistry Products AAT Reagent is used to quantitatively measure alpha-1-antitrypsin concentration in human serum. The measurement of alpha-1-antitrypsin in serum aids in the diagnosis of cirrhosis of the liver and pulmonary emphysema. For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 99 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of alpha-1-antitrypsin (AAT). For in vitro diagnostic use only. VITROS Chemistry Products AAT Performance Verifiers are assayed controls used to monitor performance of VITROS AAT Reagents on VITROS 5,1 FS Chemistry Systems.

Source page: https://510kreport.com/device/K052819
Methodology: https://510kreport.com/methodology