Cleared Traditional

K803019 - SERALYZER LDH REAGENT STRIPS

K803019 is the FDA 510(k) clearance for SERALYZER LDH REAGENT STRIPS by Miles Laboratories, Inc.. It is a Class 2 Chemistry device (product code CFJ) cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K803019 · Miles Laboratories, Inc. · Chemistry device
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Dec 1980
Decision
24d
Days
Class 2
Risk

K803019 is an FDA 510(k) clearance for the SERALYZER LDH REAGENT STRIPS, CALIBR. Classified as Nad Reduction/nadh Oxidation, Lactate Dehydrogenase (product code CFJ), Class II - Special Controls.

Submitted by Miles Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 22, 1980 after a review of 24 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 Miles Laboratories, Inc. devices

Submission Details

510(k) Number K803019 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1980
Decision Date December 22, 1980
Days to Decision 24 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
64d faster than avg
Panel avg: 88d · This submission: 24d
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 K803019.
LDH-L
K813496 · Pointe Scientific, Inc., · Dec 1981
ULTRA ZYME PLUS LDH #64950, 65038 & 39
K812590 · Harleco · Sep 1981
SPIN-CHEM LD-L REAGENT
K812472 · Smithkline Diagnostics, Inc. · Sep 1981
BECKMAN LIQUID-STAT LD-L-UV ENZYME
K802572 · Beckman Instruments, Inc. · Nov 1980
LDH (L-P) REAGENT
K800120 · Gilford Diagnostics · Feb 1980
COBAS-BLO REAGENTS (LACTATE DEHYDRO
K792658 · Hoffmann-La Roche, Inc. · Jan 1980