# K973369: Roche Unimate HDL Direct Reagen (with Pol Claim)

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostic Systems, Inc.
- Decided: Nov 21, 1997 after 74 days
- Product code: LBR (Ldl & Vldl Precipitation, Hdl)
- Device class: 1
- Regulation: 21 CFR 862.1475
- 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 K971902 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971902: Roche Unimate HDL Direct Reagent, Roche Calibrator HDL Direct, Roche Diagnostic Systems, Inc. (1997) Summary page 2.

## Indications for use
The Roche UNIMATE HDL Direct reagent is an in vitro diagnostic device intended for use in clinical and physician’s office laboratories (POL) on COBAS MIRA systems for the quantitative determination of High Density Lipoprotein Cholesterol (HDL CHOL) in serum.

Source page: https://510kreport.com/device/K973369
Methodology: https://510kreport.com/methodology