Cleared Traditional

K885134 - CLINISTAT TRIGLYCERIDES REAGENT TEST

K885134 is an FDA 510(k) clearance for CLINISTAT TRIGLYCERIDES REAGENT TEST, manufactured by Heraeus Kulzer, Inc.. The device is a Class 1 Chemistry device with product code JGY cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K885134 · Heraeus Kulzer, Inc. · Chemistry device
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Feb 1989
Decision
60d
Days
Class 1
Risk

K885134 is an FDA 510(k) clearance for the CLINISTAT TRIGLYCERIDES REAGENT TEST. Classified as Colorimetric Method, Triglycerides (product code JGY), Class I - General Controls.

Submitted by Heraeus Kulzer, Inc. (Elkhart, US). The FDA issued a Cleared decision on February 10, 1989 after a review of 60 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 Heraeus Kulzer, Inc. devices

FDA 510(k) Submission Details - K885134

510(k) Number K885134 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1988
Decision Date February 10, 1989
Days to Decision 60 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
28d faster than avg
Panel avg: 88d · This submission: 60d
Pathway characteristics
Predicate-based equivalence.

JGY Device Classification - Class 1, General Controls

Product Code JGY Colorimetric Method, 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 - JGY Colorimetric Method, Triglycerides

All 12
Devices cleared under the same product code (JGY) and FDA review panel - the closest regulatory comparables to K885134.
IL TEST(TM) TRIGLYCERIDE
K931116 · Instrumentation Laboratory CO · Mar 1994
DMA TRIGLYCERIDE (GPO) PROCEDURE
K902202 · Data Medical Associates, Inc. · Jul 1990
TRIGLYCERIDE (GPO) TRINDER REAGENT
K894063 · Sigma Diagnostics, Inc. · Sep 1989
TRIGLYCERIDES REAGENT (INT, COLORIMETRIC)
K860731 · Trace Scientific , Ltd. · Apr 1986
TRIGLYZYME V EIKEN
K821106 · Syn-Kit, Inc. · May 1982
TRIGLYCERIDE REAGENT (COLOR)
K801012 · Gilford Diagnostics · May 1980