Cleared Traditional

ALKALINE PHOSPHATASE (K905684) - FDA 510(k) Clearance

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

K905684 · Amresco, Inc. · Chemistry device
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Dec 1990
Decision
9d
Days
Class 2
Risk

K905684 is an FDA 510(k) clearance for the ALKALINE PHOSPHATASE. Classified as Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (product code CJE), Class II - Special Controls.

Submitted by Amresco, Inc. (Solon, US). The FDA issued a Cleared decision on December 28, 1990 after a review of 9 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 Amresco, Inc. devices

Submission Details

510(k) Number K905684 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 1990
Decision Date December 28, 1990
Days to Decision 9 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 88d · This submission: 9d
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 28
Devices cleared under the same product code (CJE) and FDA review panel - the closest regulatory comparables to K905684.
EMDS ALKALINE PHOSPHATASE (ALP) TEST
K924574 · Em Diagnostic Systems, Inc. · Nov 1992
ABBOTT QUICKSTART ALKA PHOSPHATASE (ALP) ITEM#5A38
K913921 · Em Diagnostic Systems, Inc. · Nov 1991
SYSTEMATE ALKALINE PHOSPHATASE(EPOS APPL) #65483
K910639 · Em Diagnostic Systems, Inc. · Apr 1991
ROCHE COBAS READY ALKALINE PHOSPHATASE REAGENT
K902560 · Roche Diagnostic Systems, Inc. · Jul 1990
SYSTEMATE(TM) ALKALINE PHOSPHATASE ITEM #65402
K895250 · Em Diagnostic Systems, Inc. · Oct 1989
ABBOTT CLINICAL CHEMISTRY REAGENT ALP
K890521 · Abbott Laboratories · Mar 1989