Cleared Traditional

K980013 - AMYLASE

K980013 is an FDA 510(k) clearance for AMYLASE, manufactured by Ac Biochemicals, Inc.. The device is a Class 2 Chemistry device with product code CIJ cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K980013 · Ac Biochemicals, Inc. · Chemistry device
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Feb 1998
Decision
33d
Days
Class 2
Risk

K980013 is an FDA 510(k) clearance for the AMYLASE. Classified as Saccharogenic, Amylase (product code CIJ), Class II - Special Controls.

Submitted by Ac Biochemicals, Inc. (Irvine, US). The FDA issued a Cleared decision on February 4, 1998 after a review of 33 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 Ac Biochemicals, Inc. devices

FDA 510(k) Submission Details - K980013

510(k) Number K980013 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 1998
Decision Date February 04, 1998
Days to Decision 33 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
55d faster than avg
Panel avg: 88d · This submission: 33d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CIJ Device Classification - Class 2, Special Controls

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 K980013.
AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS)
K023396 · Pointe Scientific, Inc., · Dec 2002
ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM
K991817 · Bayer Corp. · Jul 1999
AMYLASE (ETHYLIDENE PNGPG7) KIT
K953211 · Randox Laboratories, Ltd. · Jun 1996
AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR)
K951494 · Emd Chemicals, Inc. · Dec 1995
LIQUID AMYLASE (CNPG3) REAGENT SET
K940735 · Pointe Scientific, Inc., · Aug 1994
DMA AMYLASE (DEMAND) PROCEDURE
K940010 · Data Medical Associates, Inc. · Mar 1994