Cleared Traditional

K932888 - INTERSECT SYSTEMS DIRECT AMYLASE REAGENT

K932888 is the FDA 510(k) clearance for INTERSECT SYSTEMS DIRECT AMYLASE REAGENT by Intersect Systems, Inc.. It is a Class 2 Chemistry device (product code JFJ) cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K932888 · Intersect Systems, Inc. · Chemistry device
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Jan 1994
Decision
231d
Days
Class 2
Risk

K932888 is an FDA 510(k) clearance for the INTERSECT SYSTEMS DIRECT AMYLASE REAGENT. Classified as Catalytic Methods, Amylase (product code JFJ), Class II - Special Controls.

Submitted by Intersect Systems, Inc. (Longview, US). The FDA issued a Cleared decision on January 31, 1994 after a review of 231 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 Intersect Systems, Inc. devices

Submission Details

510(k) Number K932888 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1993
Decision Date January 31, 1994
Days to Decision 231 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
143d slower than avg
Panel avg: 88d · This submission: 231d
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 74
Devices cleared under the same product code (JFJ) and FDA review panel - the closest regulatory comparables to K932888.
CATALOGUE NUMBER 321-07/15/50
K945243 · Diagnostic Chemicals , Ltd. · Feb 1995
OLYMPUS AMYLASE REAGENT
K944229 · Olympus America, Inc. · Dec 1994
SYNERMED AMYLASE REAGENT KIT
K941091 · Synermed, Inc. · May 1994
AMYLASE REAGENT SET (KINETIC)
K931080 · Teco Diagnostics · Nov 1993
ETHYLIDENE AMYL
K931582 · Em Diagnostic Systems, Inc. · Aug 1993
SILYL AMYL
K931583 · Em Diagnostic Systems, Inc. · Aug 1993