Cleared Traditional

K921057 - AMYLASE REAGENT

K921057 is the FDA 510(k) clearance for AMYLASE REAGENT by Genzyme Corp.. It is a Class 2 Chemistry device (product code JFJ) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K921057 · Genzyme Corp. · Chemistry device
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Mar 1992
Decision
22d
Days
Class 2
Risk

K921057 is an FDA 510(k) clearance for the AMYLASE REAGENT. Classified as Catalytic Methods, Amylase (product code JFJ), Class II - Special Controls.

Submitted by Genzyme Corp. (Cambridge, US). The FDA issued a Cleared decision on March 27, 1992 after a review of 22 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 Genzyme Corp. devices

Submission Details

510(k) Number K921057 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1992
Decision Date March 27, 1992
Days to Decision 22 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 88d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JFJ Catalytic Methods, 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 - JFJ Catalytic Methods, Amylase

All 73
Devices cleared under the same product code (JFJ) and FDA review panel - the closest regulatory comparables to K921057.
OLYMPUS AMYLASE REAGENT
K923346 · Olympus Corp. · Oct 1992
MILES URINE AMYLASE METHOD
K923105 · Heraeus Kulzer, Inc. · Sep 1992
AMYLASE TEST
K923677 · Em Diagnostic Systems, Inc. · Sep 1992
ABBOTT QUICKSTART AMYLASE, #5AXX
K920583 · Em Diagnostic Systems, Inc. · Mar 1992
IL TEST(TM) AMLYLASE
K913744 · Instrumentation Laboratory CO · Feb 1992
AMYLASE REAGENT (PROCEDURE 577)
K913858 · Sigma Diagnostics, Inc. · Sep 1991