Cleared Traditional

K971398 - LD-L REAGENT

K971398 is an FDA 510(k) clearance for LD-L REAGENT, manufactured by Carolina Liquid Chemistries Corp.. The device is a Class 2 Chemistry device with product code CFJ cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K971398 · Carolina Liquid Chemistries Corp. · Chemistry device
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May 1997
Decision
17d
Days
Class 2
Risk

K971398 is an FDA 510(k) clearance for the LD-L REAGENT. Classified as Nad Reduction/nadh Oxidation, Lactate Dehydrogenase (product code CFJ), Class II - Special Controls.

Submitted by Carolina Liquid Chemistries Corp. (Brea, US). The FDA issued a Cleared decision on May 2, 1997 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1440 - 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 - K971398

510(k) Number K971398 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1997
Decision Date May 02, 1997
Days to Decision 17 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
71d faster than avg
Panel avg: 88d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CFJ Device Classification - Class 2, Special Controls

Product Code CFJ Nad Reduction/nadh Oxidation, Lactate Dehydrogenase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1440
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - CFJ Nad Reduction/nadh Oxidation, Lactate Dehydrogenase

All 102
Devices cleared under the same product code (CFJ) and FDA review panel - the closest regulatory comparables to K971398.
LACTANE DEHYDROGENASE-SL ASSAY, CATALOGUE NUMBER 327-10, 327-30
K974859 · Diagnostic Chemicals , Ltd. · Jan 1998
LIQUID LDH-L REAGENT SET
K973589 · Pointe Scientific, Inc., · Oct 1997
LACTATE DEHYDROGENASE (LD)
K970684 · Randox Laboratories, Ltd. · May 1997
LACTATE DEHYDROGENASE REAGENT SET
K961431 · Pointe Scientific, Inc., · Jun 1996
LACTATE DEHYDROGENASE REAGENT SYSTEM
K952747 · Medical Diagnostic Technologies, Inc. · Aug 1995
HICHEM LDH/L REAGENT KIT
K946022 · Hichem Diagnostics · Feb 1995