Cleared Traditional

ALKPHOR(TM) SYSTEM, HUMAN SERUM ALKA PHOS ISOENZY (K883395) - FDA 510(k) Clearance

Class I Chemistry device.

K883395 · Quantimetrix Medical Industries · Chemistry device
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Sep 1988
Decision
39d
Days
Class 1
Risk

K883395 is an FDA 510(k) clearance for the ALKPHOR(TM) SYSTEM, HUMAN SERUM ALKA PHOS ISOENZY. Classified as Enzyme Controls (assayed And Unassayed) (product code JJT), Class I - General Controls.

Submitted by Quantimetrix Medical Industries (Hawthorne, US). The FDA issued a Cleared decision on September 19, 1988 after a review of 39 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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 Quantimetrix Medical Industries devices

Submission Details

510(k) Number K883395 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1988
Decision Date September 19, 1988
Days to Decision 39 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 88d · This submission: 39d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJT Enzyme Controls (assayed And Unassayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JJT Enzyme Controls (assayed And Unassayed)

All 29
Devices cleared under the same product code (JJT) and FDA review panel - the closest regulatory comparables to K883395.
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CK-MB/LD-1 CONTROL SYSTEM
K894207 · Boehringer Mannheim Corp. · Aug 1989
DADE(R) CK-MB IMMUNOASSAY CONTROL
K882795 · Baxter Healthcare Corp · Aug 1988
TITAN GEL REP CPK/LDH ISOENZYME CONTROL
K874141 · Helena Laboratories · Nov 1987
VIRON(TM)
K872646 · bioMerieux, Inc. · Sep 1987