Cleared Traditional

K884382 - AMYLASE TEST (AMYL) ITEM NUMBER: 65653

K884382 is the FDA 510(k) clearance for AMYLASE TEST (AMYL) ITEM NUMBER: 65653 by Em Diagnostic Systems, Inc.. It is a Class 2 Chemistry device (product code CIW) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K884382 · Em Diagnostic Systems, Inc. · Chemistry device
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Jan 1989
Decision
85d
Days
Class 2
Risk

K884382 is an FDA 510(k) clearance for the AMYLASE TEST (AMYL) ITEM NUMBER: 65653. Classified as Starch-dye Bound Polymer, Amylase (product code CIW), Class II - Special Controls.

Submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on January 11, 1989 after a review of 85 days - a notably fast clearance 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: 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 Em Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K884382 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1988
Decision Date January 11, 1989
Days to Decision 85 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 88d · This submission: 85d
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 K884382.
DMA AMYLASE PROCEDURE
K931559 · Data Medical Associates, Inc. · Oct 1993
OLYMPUS AMYLASE REAGENT
K924339 · Olympus Corp. · Oct 1992
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