Cleared Traditional

K973589 - LIQUID LDH-L REAGENT SET

K973589 is an FDA 510(k) clearance for LIQUID LDH-L REAGENT SET, manufactured by Pointe Scientific, Inc.,. The device is a Class 2 Chemistry device with product code CFJ cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K973589 · Pointe Scientific, Inc., · Chemistry device
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Oct 1997
Decision
16d
Days
Class 2
Risk

K973589 is an FDA 510(k) clearance for the LIQUID LDH-L REAGENT SET. Classified as Nad Reduction/nadh Oxidation, Lactate Dehydrogenase (product code CFJ), Class II - Special Controls.

Submitted by Pointe Scientific, Inc., (Lincoln Park, US). The FDA issued a Cleared decision on October 8, 1997 after a review of 16 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 Pointe Scientific, Inc., devices

FDA 510(k) Submission Details - K973589

510(k) Number K973589 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 1997
Decision Date October 08, 1997
Days to Decision 16 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
72d faster than avg
Panel avg: 88d · This submission: 16d
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 104
Devices cleared under the same product code (CFJ) and FDA review panel - the closest regulatory comparables to K973589.
ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, ACE LDH-L REAGENT
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LACTANE DEHYDROGENASE-SL ASSAY, CATALOGUE NUMBER 327-10, 327-30
K974859 · Diagnostic Chemicals , Ltd. · Jan 1998
LACTATE DEHYDROGENASE (LD)
K970684 · Randox Laboratories, Ltd. · May 1997
LD-L REAGENT
K971398 · Carolina Liquid Chemistries Corp. · May 1997
LACTATE DEHYDROGENASE
K964912 · Derma Media Lab., Inc. · Jan 1997