Cleared Traditional

K832889 - AMYLASE

K832889 is an FDA 510(k) clearance for AMYLASE, manufactured by Pointe Scientific, Inc.,. The device is a Class 2 Chemistry device with product code JFJ cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K832889 · Pointe Scientific, Inc., · Chemistry device
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Nov 1983
Decision
95d
Days
Class 2
Risk

K832889 is an FDA 510(k) clearance for the AMYLASE. Classified as Catalytic Methods, Amylase (product code JFJ), Class II - Special Controls.

Submitted by Pointe Scientific, Inc., (Mchenry, US). The FDA issued a Cleared decision on November 25, 1983 after a review of 95 days - within the typical 510(k) review window.

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

FDA 510(k) Submission Details - K832889

510(k) Number K832889 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 1983
Decision Date November 25, 1983
Days to Decision 95 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
7d slower than avg
Panel avg: 88d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JFJ Device Classification - Class 2, Special Controls

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 93
Devices cleared under the same product code (JFJ) and FDA review panel - the closest regulatory comparables to K832889.
ENZYMATIC ALPHA-AMYLASE REAGENT KIT
K860245 · Bio-Analytics Laboratories, Inc. · Mar 1986
AMY REAGENT
K852001 · Alpkem Corp. · Jun 1985
AMYLASE PRODUCTS
K850798 · Data Medical Associates, Inc. · Mar 1985
AMYLAST-D TEST
K831561 · Sclavo, Inc. · Jul 1983
PARAMAX AMALINE REAGENT
K831536 · American Dade · Jun 1983
SINGLE VIAL AMYLASE PNP TEST
K823462 · Boehringer Mannheim Corp. · Dec 1982