# K063852: Accessa Cholesterol Panel

- Pathway: 510(k) (Traditional)
- Applicant: Home Access Health Corp.
- Decided: Nov 9, 2007 after 316 days
- Product code: JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection)
- Device class: 2
- Regulation: 21 CFR 862.1675
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K781939 (1979). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012221: Safe at Home Cholesterol Profile Blood Collection and Transport System, Biosafe Laboratories, Inc. (2002) Summary page 1.
- K891922: Amresco Cholesterol Reagents, Prod. # 7325, American Research Products Co. (1989) Summary page 1.
- K801834: Wako HDL Cholesterol Test, Wako Pure Chemical Industries, Ltd. (1980) Summary page 1.
- K801298: Cobas Reagent for Triglycerides & Cobas, Roche Analytical Instruments, Inc. (1980) Summary page 1.

## Indications for use
The accessa Cholesterol Panel is intended for in vitro, quantitative determination of Total Cholesterol, HDL-Cholesterol, Triglycerides and calculated LDL-Cholesterol in dried micro-serum samples ("Cholesterol Panel"). Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis and various liver and renal diseases. The Cholesterol Panel is not intended for use on neonates. LDL-Cholesterol cannot be determined where the triglycerides value is greater than 400 mg/dL.

Source page: https://510kreport.com/device/K063852
Methodology: https://510kreport.com/methodology