# K972638: Tina-Quant Prealbumin

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Jan 9, 1998 after 178 days
- Product code: JZJ (Prealbumin, Antigen, Antiserum, Control)
- Device class: 1
- Regulation: 21 CFR 866.5060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Behring BN® Prealbumin assay: named in the summary without a submission number

## Indications for use
Immunological latex agglutination test for the in vitro quantitative determination of prealbumin in human serum and plasma. Measurement of prealbumin levels in serum may aid in the assessment of the patient’s nutritional status.

Source page: https://510kreport.com/device/K972638
Methodology: https://510kreport.com/methodology