Cleared Traditional

K960377 - ENA-C-T TOTAL CHOLESTEROL TEST

K960377 is an FDA 510(k) clearance for ENA-C-T TOTAL CHOLESTEROL TEST, manufactured by Actimed Laboratories, Inc.. The device is a Class 1 Chemistry device with product code CHH cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K960377 · Actimed Laboratories, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1996
Decision
97d
Days
Class 1
Risk

K960377 is an FDA 510(k) clearance for the ENA-C-T TOTAL CHOLESTEROL TEST. Classified as Enzymatic Esterase--oxidase, Cholesterol (product code CHH), Class I - General Controls.

Submitted by Actimed Laboratories, Inc. (Burlington, US). The FDA issued a Cleared decision on May 2, 1996 after a review of 97 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 Actimed Laboratories, Inc. devices

FDA 510(k) Submission Details - K960377

510(k) Number K960377 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 1996
Decision Date May 02, 1996
Days to Decision 97 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
9d slower than avg
Panel avg: 88d · This submission: 97d
Pathway characteristics
Predicate-based equivalence.

CHH Device Classification - Class 1, General Controls

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 183
Devices cleared under the same product code (CHH) and FDA review panel - the closest regulatory comparables to K960377.
PARAMAX CHOLESTEROL REAGENT
K964660 · Dade Intl., Inc. · Jun 1997
CHOL OR CHOLESTEROL
K971345 · Carolina Liquid Chemistries Corp. · May 1997
CHOLESTEROL-INCORPORATING DYNAMIC STAB TECH (DST)
K962890 · Trace Scientific , Ltd. · Sep 1996
ACCU-CHEK INSTANT PLUS CHOLOESTEROL TEST
K944458 · Boehringer Mannheim Corp. · Mar 1996
DMA TOTAL CHOLESTEROL PROCEDURE
K946161 · Data Medical Associates, Inc. · Aug 1995
BOEHRINGER MANNHEIM CHOLESTEROL ASSAY
K952127 · Boehringer Mannheim Corp. · Jul 1995