# K991733: Ace LDL-C Reagent, LDL-C Calibrator, LDL-C Controls

- Pathway: 510(k) (Traditional)
- Applicant: Schiapparelli Biosystems, Inc.
- Decided: Jul 13, 1999 after 53 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 K971573 (1997). 1 ancestor in all.
4 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971573: N-Geneous LDL Cholesterol Reagent, N-Geneous LDL Cholesterol Calibrator, Genzyme LDL Cholesterol Control Set, Genzyme Corp. (1997) Summary page 1.

## Most influential descendants
- K113262: Ace Cholesterol Reagent, Ace HDL-C Reagent, Ace LDL-C Reagent-C, Ace-Trislycerides Reagent (2012), 1 descendant of its own
- K122757: Ace Cholesterol Reagent, Ace HDL-C Reagent, Ace LDL-C Reagent, Ace Triglycerides Reagent (2012), 0 descendants of its own
- K112538: Ace Cholesterol Reagent, Ace HDL-C Reagent, Ace LDL-C Reagent, Ace Triglycerides Reagent (2012), 0 descendants of its own
- K091333: S-Test LDL Cholesterol (LDL), Model RC0022 (2009), 0 descendants of its own

## Indications for use
ACE® LDL-C Reagent is intended for the quantitative determination of LDL cholesterol in serum using the ACE® clinical chemistry system. LDL-C Calibrator is intended for the calibration of the ACE® LDL-C Assay. LDL-C Controls are intended to monitor the performance of the ACE® LDL-C Assay. The measurement of LDL cholesterol is a factor in the pathogenesis of atherosclerosis and coronary artery disease.

Source page: https://510kreport.com/device/K991733
Methodology: https://510kreport.com/methodology