# K982848: Cobas Integra LDL Direct Reagent Cassette Roche Calibrator LDL Direct

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostic Systems, Inc.
- Decided: Oct 1, 1998 after 50 days
- Product code: MRR (System, Test, Low Density, Lipoprotein)
- 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 K922043 (1992). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K924674: Direct LDL Choles Immunoseparation Reagent, Genzyme Corp. (1993) Summary page 2.
- K922043: Roche Calibrator Serum, Roche Diagnostic Systems, Inc. (1992) Summary page 2.

## Indications for use
The cassette COBAS INTEGRA LDL Direct (LDL-D) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA 700 for the quantitative determination of LDL-cholesterol direct concentration in serum and plasma. Low density lipoprotein cholesterol measurement, in conjunction with other lipid determinations, has been shown to be useful in assessing the risk of coronary heart disease. The Roche Calibrator LDL Direct is intended for use as calibrator in quantitative Low Density Lipoprotein cholesterol assays. It is recommended for use with LDL Direct reagents on COBAS® chemistry systems. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens.

Source page: https://510kreport.com/device/K982848
Methodology: https://510kreport.com/methodology