Cleared Traditional

K935175 - LACTATE DEHYDROGENASE (LD)

K935175 is the FDA 510(k) clearance for LACTATE DEHYDROGENASE (LD) by Em Diagnostic Systems, Inc.. It is a Class 2 Chemistry device (product code CFJ) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K935175 · Em Diagnostic Systems, Inc. · Chemistry device
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Dec 1993
Decision
50d
Days
Class 2
Risk

K935175 is an FDA 510(k) clearance for the LACTATE DEHYDROGENASE (LD). Classified as Nad Reduction/nadh Oxidation, Lactate Dehydrogenase (product code CFJ), Class II - Special Controls.

Submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on December 16, 1993 after a review of 50 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 Em Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K935175 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1993
Decision Date December 16, 1993
Days to Decision 50 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
38d faster than avg
Panel avg: 88d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 82
Devices cleared under the same product code (CFJ) and FDA review panel - the closest regulatory comparables to K935175.
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
LACTATE DEHYDROGENASE (LD) TEST ITEM #65418
K924703 · Em Diagnostic Systems, Inc. · Feb 1993
OLYMPUS LACTATE DEHYDROGENASE REAGENT
K924965 · Olympus Corp. · Nov 1992
OLYMPUS LACTATE DEHYDROGENASE REAGENT
K923412 · Olympus Corp. · Sep 1992