Cleared Traditional

K831295 - AMYLASE REAGENT #88129

K831295 is an FDA 510(k) clearance for AMYLASE REAGENT #88129, manufactured by Hi Chem, Inc.. The device is a Class 2 Chemistry device with product code KHM cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K831295 · Hi Chem, Inc. · Chemistry device
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Jun 1983
Decision
71d
Days
Class 2
Risk

K831295 is an FDA 510(k) clearance for the AMYLASE REAGENT #88129. Classified as Nephelometric, Amylase (product code KHM), Class II - Special Controls.

Submitted by Hi Chem, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 30, 1983 after a review of 71 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.

FDA 510(k) Submission Details - K831295

510(k) Number K831295 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1983
Decision Date June 30, 1983
Days to Decision 71 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
18d faster than avg
Panel avg: 89d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KHM Device Classification - Class 2, Special Controls

Product Code KHM Nephelometric, 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 - KHM Nephelometric, Amylase

Devices cleared under the same product code (KHM) and FDA review panel - the closest regulatory comparables to K831295.
AMYLASE
K812699 · Pointe Scientific, Inc., · Oct 1981
AMYLASE REAGENT KIT
K812447 · Bioscientific · Sep 1981
PERKIN ELMER MODEL 91 AMYLASE REAGENT
K801096 · Stat Engineering · Jun 1980
AMYLASE REAGENT SET
K790797 · Alta Diagnostics, Inc. · Jul 1979
REAGENT, AMYLASE LIPASE
K770400 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1977
K831295 · AMYLASE REAGENT #88129
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