Cleared Traditional

K832889 - AMYLASE

K832889 is the FDA 510(k) clearance for AMYLASE by Pointe Scientific, Inc.,. It is a Class 2 Chemistry device (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

Submission Details

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.

Device Classification

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 72
Devices cleared under the same product code (JFJ) and FDA review panel - the closest regulatory comparables to K832889.
ALPHA-AMYLASE TEST
K860665 · Sclavo, Inc. · Apr 1986
EASY-TEST AMLASE (AMYL), #67521/93
K860918 · Em Diagnostic Systems, Inc. · Apr 1986
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