Cleared Traditional

K971324 - TRIGLYCERIDES

K971324 is an FDA 510(k) clearance for TRIGLYCERIDES, manufactured by Carolina Liquid Chemistries Corp.. The device is a Class 1 Chemistry device with product code CDT cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K971324 · Carolina Liquid Chemistries Corp. · Chemistry device
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Jun 1997
Decision
71d
Days
Class 1
Risk

K971324 is an FDA 510(k) clearance for the TRIGLYCERIDES, TG, OR TRIG. Classified as Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides (product code CDT), Class I - General Controls.

Submitted by Carolina Liquid Chemistries Corp. (Brea, US). The FDA issued a Cleared decision on June 20, 1997 after a review of 71 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 Carolina Liquid Chemistries Corp. devices

FDA 510(k) Submission Details - K971324

510(k) Number K971324 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1997
Decision Date June 20, 1997
Days to Decision 71 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 88d · This submission: 71d
Pathway characteristics
Predicate-based equivalence.

CDT Device Classification - Class 1, General Controls

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 130
Devices cleared under the same product code (CDT) and FDA review panel - the closest regulatory comparables to K971324.
CARESIDE TRGLYCERIDE
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K010871 · Dade Behring, Inc. · Jul 2001
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DMA TRIGLYCERIDES PROCEDURES
K971113 · Data Medical Associates, Inc. · May 1997
PARAMAX TRIGLYCERID REAGENT
K964346 · Dade Intl., Inc. · Mar 1997
OLYMPUS LIPASE REAGENT
K963424 · Olympus America, Inc. · Jan 1997