Cleared Traditional

AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS) (K023396) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K023396 · Pointe Scientific, Inc., · Chemistry device
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Dec 2002
Decision
75d
Days
Class 2
Risk

K023396 is an FDA 510(k) clearance for the AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS). Classified as Saccharogenic, Amylase (product code CIJ), Class II - Special Controls.

Submitted by Pointe Scientific, Inc., (Lincoln Park, US). The FDA issued a Cleared decision on December 23, 2002 after a review of 75 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 Pointe Scientific, Inc., devices

Submission Details

510(k) Number K023396 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 2002
Decision Date December 23, 2002
Days to Decision 75 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
13d faster than avg
Panel avg: 88d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CIJ Saccharogenic, 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 - CIJ Saccharogenic, Amylase

All 30
Devices cleared under the same product code (CIJ) and FDA review panel - the closest regulatory comparables to K023396.
-AMYLASE EPS
K882225 · Boehringer Mannheim Corp. · Jan 1989
ISOMUNE-AMYLASE AND ISOMUNE-AMYLASE CONTROL
K873250 · Roche Diagnostic Systems, Inc. · Oct 1987
IL 35260, IL TEST AMYLASE REAGENT
K873572 · Instrumentation Laboratory CO · Oct 1987
EMDS AMYLASE (AMYL) TEST PACKS, # 67653/95
K860935 · Em Diagnostic Systems, Inc. · May 1986
SYSTEMATE A AMYLASE HEM 67204
K843645 · Em Diagnostic Systems, Inc. · Sep 1984
ENZYMATIC AMYLASE REAGENT KIT
K760415 · Beckman Instruments, Inc. · Nov 1976