Cleared Traditional

K873160 - BIOTROL TRIGLYCERIDES ENZYMATIQUE COLOR

K873160 is the FDA 510(k) clearance for BIOTROL TRIGLYCERIDES ENZYMATIQUE COLOR by Biotrol, USA, Inc.. It is a Class 1 Chemistry device (product code CDT) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K873160 · Biotrol, USA, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1987
Decision
28d
Days
Class 1
Risk

K873160 is an FDA 510(k) clearance for the BIOTROL TRIGLYCERIDES ENZYMATIQUE COLOR. Classified as Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides (product code CDT), Class I - General Controls.

Submitted by Biotrol, USA, Inc. (Berwyn, US). The FDA issued a Cleared decision on September 8, 1987 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1705 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Biotrol, USA, Inc. devices

Submission Details

510(k) Number K873160 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1987
Decision Date September 08, 1987
Days to Decision 28 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 88d · This submission: 28d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CDT Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1705
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 - CDT Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides

All 114
Devices cleared under the same product code (CDT) and FDA review panel - the closest regulatory comparables to K873160.
TRIGLYCERIDES (GPO-TRINDER)
K880628 · Tech-Co, Inc. · Mar 1988
A-GENT TRIGLLYCERIDES GPO
K874187 · Abbott Laboratories · Jan 1988
TRIGLYERIDES TEST KIT
K874584 · Ciba Corning Diagnostics Corp. · Jan 1988
TRIGLYCERIDES GPO WITHOUT FREE GLYCEROL
K873049 · Boehringer Mannheim Corp. · Aug 1987
RESUBMITTED TRIGLYCERIDE GPO - TWO VIAL
K871508 · Trace Scientific , Ltd. · May 1987
RESUBMITTED TRIGLYCERIDE GPO REAGENT (SINGLE VIAL)
K871509 · Trace Scientific , Ltd. · May 1987