Cleared Traditional

K931559 - DMA AMYLASE PROCEDURE

K931559 is the FDA 510(k) clearance for DMA AMYLASE PROCEDURE by Data Medical Associates, Inc.. It is a Class 2 Chemistry device (product code CIW) cleared through the Traditional 510(k) pathway after a 212-day FDA review.

K931559 · Data Medical Associates, Inc. · Chemistry device
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Oct 1993
Decision
212d
Days
Class 2
Risk

K931559 is an FDA 510(k) clearance for the DMA AMYLASE PROCEDURE. Classified as Starch-dye Bound Polymer, Amylase (product code CIW), Class II - Special Controls.

Submitted by Data Medical Associates, Inc. (Arlington, US). The FDA issued a Cleared decision on October 28, 1993 after a review of 212 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1070 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Data Medical Associates, Inc. devices

Submission Details

510(k) Number K931559 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1993
Decision Date October 28, 1993
Days to Decision 212 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
124d slower than avg
Panel avg: 88d · This submission: 212d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CIW Starch-dye Bound Polymer, Amylase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1070
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 - CIW Starch-dye Bound Polymer, Amylase

Devices cleared under the same product code (CIW) and FDA review panel - the closest regulatory comparables to K931559.
OLYMPUS AMYLASE REAGENT
K924339 · Olympus Corp. · Oct 1992
AMYLASE TEST (AMYL) ITEM NUMBER: 65653
K884382 · Em Diagnostic Systems, Inc. · Jan 1989
KODAK EKTACHEM CLIN. CHEM. SLIDES (AMYL)
K812027 · Eastman Kodak Company · Aug 1981
PHADEBAS ISOAMYLASE TEST
K810584 · Pharmacia, Inc. · May 1981
PANTRAK E.K.
K810669 · Calbiochem-Behring Corp. · Mar 1981
UNITEST AMYLASE
K782032 · Boehringer Mannheim Corp. · Mar 1979