Cleared Traditional

K011970 - BIOSAFE CHOLESTEROL PROFILE BLOOD COLLE...

K011970 is the FDA 510(k) clearance for BIOSAFE CHOLESTEROL PROFILE BLOOD COLLE... by Biosafe Laboratories, Inc.. It is a Class 1 Chemistry device (product code CHH) cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K011970 · Biosafe Laboratories, Inc. · Chemistry device
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Sep 2001
Decision
93d
Days
Class 1
Risk

K011970 is an FDA 510(k) clearance for the BIOSAFE CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM. Classified as Enzymatic Esterase--oxidase, Cholesterol (product code CHH), Class I - General Controls.

Submitted by Biosafe Laboratories, Inc. (Lake Forest, US). The FDA issued a Cleared decision on September 26, 2001 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1175 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Biosafe Laboratories, Inc. devices

Submission Details

510(k) Number K011970 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 2001
Decision Date September 26, 2001
Days to Decision 93 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 88d · This submission: 93d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CHH Enzymatic Esterase--oxidase, Cholesterol
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1175
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - CHH Enzymatic Esterase--oxidase, Cholesterol

All 122
Devices cleared under the same product code (CHH) and FDA review panel - the closest regulatory comparables to K011970.
EASYRA CHOLESTEROL REAGENT
K072249 · Medica Corp. · Feb 2008
ACCUCHEK INSTANT PLUS DUAL TESTING SYSTEM, ACCUCHEK INSTANT PLUS CHOLESTEROL, ACCUCHEK INSTANT PLUS GLUCOCOSE
K051376 · Roche Diagnostics · Aug 2005
COBAS INTEGRA CHOLESTEROL GEN. 2
K031824 · Roche Diagnostics Corp. · Jul 2003
SIGMA DIAGNOSTICS INFINITY CHOLESTEROL REAGENT, MODELS 401-25, 401-100P, 401-500P, 401-2000P, 402-20, 02-1OOP
K992803 · Sigma Diagnostics, Inc. · Sep 1999
CHOL
K981652 · Abbott Laboratories · Jun 1998
CHOL
K981476 · Abbott Laboratories · Jun 1998