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Safe at Home Cholesterol Profile Blood Collection and Transport System

by Biosafe Laboratories, Inc.

510(k) K012221

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK012221 Date3 Apr 2002ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JKA
Device Class
Class II
Regulation
21 CFR Part 862.1675
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Safe at Home Cholesterol Profile Blood Collection and Transport System is a device designed for the collection and transport of capillary blood samples for lipid profile testing. It is substantially equivalent to venous serum samples for the determination of total cholesterol, HDL cholesterol, and triglycerides.

The system is intended for use in self-collected capillary blood sampling, typically in a home or point-of-care setting. It is supplied as a non-sterile, single-use device and has received FDA 510(k) clearance under K012221 with product code JKA.

Other devices from Biosafe Laboratories, Inc.