Cleared Traditional

K772035 - GEMSAEC APPLI. FOR ULTRAZYME PLUS Y-AMYL

K772035 is the FDA 510(k) clearance for GEMSAEC APPLI. FOR ULTRAZYME PLUS Y-AMYL by Harleco. It is a Class 2 Chemistry device (product code JFJ) cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K772035 · Harleco · Chemistry device
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Nov 1977
Decision
21d
Days
Class 2
Risk

K772035 is an FDA 510(k) clearance for the GEMSAEC APPLI. FOR ULTRAZYME PLUS Y-AMYL. Classified as Catalytic Methods, Amylase (product code JFJ), Class II - Special Controls.

Submitted by Harleco (Mchenry, US). The FDA issued a Cleared decision on November 17, 1977 after a review of 21 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 Harleco devices

Submission Details

510(k) Number K772035 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1977
Decision Date November 17, 1977
Days to Decision 21 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
67d faster than avg
Panel avg: 88d · This submission: 21d
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 72
Devices cleared under the same product code (JFJ) and FDA review panel - the closest regulatory comparables to K772035.
ULTRAZYME PLUS AMYL #65031&64982
K821459 · Emd Chemicals, Inc. · May 1982
BEKCMAN ASTRA SYSTEMS AMYLASE CHEMISTRY
K802581 · Beckman Instruments, Inc. · Nov 1980
DELTA TEST AMYLASE UV
K800049 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1980
MULTISTAT III, AMYLASE TEST
K771622 · Instrumentation Laboratory CO · Sep 1977
AMYLASE ULTRAZYME PLUS
K771388 · Harleco · Sep 1977
CLINICARD UV AMYLASE CHEMISTRY
K771131 · Harleco · Jul 1977