# K011970: Biosafe Cholesterol Profile Blood Collection and Transport System

- Pathway: 510(k) (Traditional)
- Applicant: Biosafe Laboratories, Inc.
- Decided: Sep 26, 2001 after 93 days
- Product code: CHH (Enzymatic Esterase--Oxidase, Cholesterol)
- Device class: 1
- Regulation: 21 CFR 862.1175
- 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 K781939 (1979). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934046: Beckman Cholesterol Reagent, Beckman-Diagnostic Systems Group (1993). Our OCR of the scanned summary read K974046, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Beckman Synchron Synchron CX Systems Cholesterol (CHOL) Reagent”.
- K972041: EZ HDL Cholesterol Reagent (Procedure 354)/EZ HDL Calibrator (354-5), Sigma Diagnostics, Inc. (1997) Summary page 1.
- K781939: Reagent Kit, Triglycerides, Beckman Instruments, Inc. (1979) Summary page 1.

## Indications for use
The BIOSAFE CHOLESTEROL PROFILE Blood Collection and Transport System is intended for prescription distribution, and is a clinic-use device for collection and transportation of dried capillary blood for in vitro diagnostic quantitative determination of Total Cholesterol, HDL-Cholesterol, Triglycerides and Calculated LDL-Cholesterol in dried blood spots. This kit is not intended for use on neonates. LDL cannot be determined where the triglyceride value is greater than 400 mg/dL.

Source page: https://510kreport.com/device/K011970
Methodology: https://510kreport.com/methodology