Cleared Traditional

K861638 - KINETIC ALKALINE PHOSPHATASE REAGENT KIT

K861638 is the FDA 510(k) clearance for KINETIC ALKALINE PHOSPHATASE REAGENT KIT by Bio-Analytics Laboratories, Inc.. It is a Class 2 Chemistry device (product code CJE) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K861638 · Bio-Analytics Laboratories, Inc. · Chemistry device
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May 1986
Decision
29d
Days
Class 2
Risk

K861638 is an FDA 510(k) clearance for the KINETIC ALKALINE PHOSPHATASE REAGENT KIT. Classified as Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (product code CJE), Class II - Special Controls.

Submitted by Bio-Analytics Laboratories, Inc. (Palm City, US). The FDA issued a Cleared decision on May 29, 1986 after a review of 29 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 K861638 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 1986
Decision Date May 29, 1986
Days to Decision 29 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 88d · This submission: 29d
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 K861638.
ALP S.C.E.
K863051 · J. D. Assoc. · Sep 1986
ALP (OPT) REAGENT
K862905 · Sigma Diagnostics, Inc. · Aug 1986
ALKALINE PHOSPHATASE (PNPP RATE) REAGENT SET
K862256 · Sterling Diagnostics, Inc. · Jul 1986
ALKALINE PHOSPHATASE PROCEDURE
K861667 · Data Medical Associates, Inc. · May 1986
AP REAGENT CARTRIDGE
K861284 · Hi Chem, Inc. · Apr 1986
ALP (ALKALINE PHOSPHATASE) REAGENT
K860715 · Trace Scientific , Ltd. · Apr 1986