# K992002: Autohdl Cholesterol Reagent Set

- Pathway: 510(k) (Traditional)
- Applicant: Pointe Scientific, Inc.,
- Decided: Aug 5, 1999 after 51 days
- Product code: LBR (Ldl & Vldl Precipitation, Hdl)
- Device class: 1
- Regulation: 21 CFR 862.1475
- Recalls of this device: 13 (0 Class I)
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Aug 10, 2018 · Class III · Z-0389-2019: Vials of the autoHDL/LDL Calibrator were shipped without a vial label.
- Mar 13, 2015 · Class III · Z-2764-2015: Crystals may be observed in the R1 reagent. Crystals may be a result of the reagent being frozen during transport. The crystals do not impact product performance.
- Jan 29, 2009 · Not classified · Z-1200-2009: The R1 reagent has microbial contamination.
- Jan 29, 2009 · Not classified · Z-1201-2009: The R1 reagent has microbial contamination.
- Sep 18, 2006 · Not classified · Z-0074-2007: Unexpected changes in QC and proficiency results due to QC and proficiency material matrix.
- Sep 18, 2006 · Not classified · Z-0075-2007: Unexpected changes in QC and proficiency results due to QC and proficiency material matrix.
- Sep 18, 2006 · Not classified · Z-0076-2007: Unexpected changes in QC and proficiency results due to QC and proficiency material matrix.
- Jun 12, 2006 · Not classified · Z-1454-06: Unexpected changes in QC and proficiency results due to QC and proficiency material matrix.
- Jun 12, 2006 · Not classified · Z-1457-06: Unexpected changes in QC and proficiency results due to QC and proficiency material matrix.
- Jun 12, 2006 · Not classified · Z-1455-06: Unexpected changes in QC and proficiency results due to QC and proficiency material matrix.
- Jun 12, 2006 · Not classified · Z-1458-06: Unexpected changes in QC and proficiency results due to QC and proficiency material matrix.
- Jun 12, 2006 · Not classified · Z-1459-06: Unexpected changes in QC and proficiency results due to QC and proficiency material matrix.
- Jun 12, 2006 · Not classified · Z-1456-06: Unexpected changes in QC and proficiency results due to QC and proficiency material matrix.

## Indications for use
This product is to be used in a diagnostic laboratory setting, by qualified laboratory technologists, for the quantitative determination of high density lipoprotein (HDL) cholesterol in serum or plasma. HDL cholesterol is recognized as a useful tool in identifying patients who are at a higher risk for coronary heart disease. Low HDL cholesterol levels are associated with an increased risk. This reagent set is intended for in vitro diagnostic use only.

Source page: https://510kreport.com/device/K992002
Methodology: https://510kreport.com/methodology