Cleared Traditional

K873520 - PARAMAX AMYLASE REAGENT

K873520 is the FDA 510(k) clearance for PARAMAX AMYLASE REAGENT by Baxter Healthcare Corp. It is a Class 2 Chemistry device (product code CJA) cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K873520 · Baxter Healthcare Corp · Chemistry device
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Nov 1987
Decision
83d
Days
Class 2
Risk

K873520 is an FDA 510(k) clearance for the PARAMAX AMYLASE REAGENT. Classified as Amyloclastic, Amylase (product code CJA), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Santa Ana, US). The FDA issued a Cleared decision on November 23, 1987 after a review of 83 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 Baxter Healthcare Corp devices

Submission Details

510(k) Number K873520 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1987
Decision Date November 23, 1987
Days to Decision 83 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
5d faster than avg
Panel avg: 88d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CJA Amyloclastic, 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 - CJA Amyloclastic, Amylase

All 7
Devices cleared under the same product code (CJA) and FDA review panel - the closest regulatory comparables to K873520.
MODIFIED HI CHEM AMYLASE REAGENT (PRODUCT #88129)
K895555 · Hichem Diagnostics · Dec 1989
WAKO(TM) AUTOKIT AMYLASE
K883059 · Wako Chemicals USA, Inc. · Aug 1988
AMYLASE LTS
K862640 · Electro-Nucleonics Laboratories, Inc. · Sep 1986
ALPHA AMYLASE
K863052 · J. D. Assoc. · Sep 1986
AMYLASE REAGENT SET (MODIFIED CARAWAY)
K860530 · Sterling Diagnostics, Inc. · Feb 1986
AMYLASE REAGENT CS-726
K844168 · Fisher Scientific Co., LLC · Nov 1984