Cleared Traditional

K930475 - LIQUID AMYLASE REAGENT SET

K930475 is the FDA 510(k) clearance for LIQUID AMYLASE REAGENT SET by Pointe Scientific, Inc.,. It is a Class 2 Chemistry device (product code JFJ) cleared through the Traditional 510(k) pathway after a 172-day FDA review.

K930475 · Pointe Scientific, Inc., · Chemistry device
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Jul 1993
Decision
172d
Days
Class 2
Risk

K930475 is an FDA 510(k) clearance for the LIQUID AMYLASE REAGENT SET. Classified as Catalytic Methods, Amylase (product code JFJ), Class II - Special Controls.

Submitted by Pointe Scientific, Inc., (Lincoln Park, US). The FDA issued a Cleared decision on July 19, 1993 after a review of 172 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 Pointe Scientific, Inc., devices

Submission Details

510(k) Number K930475 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 1993
Decision Date July 19, 1993
Days to Decision 172 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
84d slower than avg
Panel avg: 88d · This submission: 172d
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 K930475.
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
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