Cleared Traditional

ALKPHOR SYSTEM (K823445) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K823445 · California Immuno Diagnostic, Inc. · Chemistry device
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Dec 1982
Decision
42d
Days
Class 2
Risk

K823445 is an FDA 510(k) clearance for the ALKPHOR SYSTEM. Classified as Electrophoretic Separation, Alkaline Phosphatase Isoenzymes (product code CIN), Class II - Special Controls.

Submitted by California Immuno Diagnostic, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 28, 1982 after a review of 42 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 California Immuno Diagnostic, Inc. devices

Submission Details

510(k) Number K823445 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1982
Decision Date December 28, 1982
Days to Decision 42 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 88d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CIN Electrophoretic Separation, Alkaline Phosphatase 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 - CIN Electrophoretic Separation, Alkaline Phosphatase Isoenzymes

All 25
Devices cleared under the same product code (CIN) and FDA review panel - the closest regulatory comparables to K823445.
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ACCESS OSTASE IMMUNOENZYMETRIC ASSAY
K994278 · Beckman Coulter, Inc. · Mar 2000
TITAN GEL ALKALINE PHOSPHATASE (HR)
K921578 · Helena Laboratories · Sep 1992
REP ALP-15, 8, & 4 KITS
K912603 · Helena Laboratories · Jul 1991