Cleared Traditional

K810082 - ALKALINE PHOSPH.

K810082 is the FDA 510(k) clearance for ALKALINE PHOSPH. by Bio-Analytics Laboratories, Inc.. It is a Class 2 Chemistry device (product code CJE) cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K810082 · Bio-Analytics Laboratories, Inc. · Chemistry device
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Jan 1981
Decision
13d
Days
Class 2
Risk

K810082 is an FDA 510(k) clearance for the ALKALINE PHOSPH., LIQUID ENZY., KIN. KIT. Classified as Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (product code CJE), Class II - Special Controls.

Submitted by Bio-Analytics Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 26, 1981 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1050 - 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 Bio-Analytics Laboratories, Inc. devices

Submission Details

510(k) Number K810082 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1981
Decision Date January 26, 1981
Days to Decision 13 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 88d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1050
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 - CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes

All 86
Devices cleared under the same product code (CJE) and FDA review panel - the closest regulatory comparables to K810082.
GILCHEM ALP REAGENT
K812912 · Gilford Diagnostics · Nov 1981
ULTRA ZYME PLUS ALP #64962, 65029 & 30
K812596 · Harleco · Sep 1981
ALKALINE PHOSPHATASE
K812452 · Pointe Scientific, Inc., · Sep 1981
BECKMAN LIQUID STAT LIQUID/ALKALINE PHO
K802574 · Beckman Instruments, Inc. · Nov 1980
CENTRIFICHEM ALP/ALKALINE PHOSPHATASE
K800131 · Union Carbide Corp. · Feb 1980
ELVI ALKALINE PHOSPHATATASE
K792413 · Volu Sol Medical Industries · Dec 1979