# K971902: Roche Unimate HDL Direct Reagent, Roche Calibrator HDL Direct

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostic Systems, Inc.
- Decided: Jun 16, 1997 after 24 days
- Product code: LBS (Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K973369: Roche Unimate HDL Direct Reagen (with Pol Claim) (1997), 0 descendants of its own

## Indications for use
1. The Roche UNIMATE HDL Direct reagent is an in vitro diagnostic test for the quantitative determination of High Density Lipoprotein Cholesterol (HDL CHOL) in serum. 2. The Roche Calibrator HDL Direct is intended for use as calibrator in quantitative High Density Lipoprotein Cholesterol (HDL CHOL) assays.

Source page: https://510kreport.com/device/K971902
Methodology: https://510kreport.com/methodology