Cleared Traditional

K864464 - PSI AMYLASE REAGENT

K864464 is the FDA 510(k) clearance for PSI AMYLASE REAGENT by Pointe Scientific, Inc.,. It is a Class 2 Chemistry device (product code JFJ) cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K864464 · Pointe Scientific, Inc., · Chemistry device
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Jan 1987
Decision
70d
Days
Class 2
Risk

K864464 is an FDA 510(k) clearance for the PSI AMYLASE REAGENT. Classified as Catalytic Methods, Amylase (product code JFJ), Class II - Special Controls.

Submitted by Pointe Scientific, Inc., (Detroit, US). The FDA issued a Cleared decision on January 21, 1987 after a review of 70 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 Pointe Scientific, Inc., devices

Submission Details

510(k) Number K864464 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1986
Decision Date January 21, 1987
Days to Decision 70 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: 88d · This submission: 70d
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 K864464.
STANBIO ALPHA-AMYLASE TEST SET, CATALOG 0180-715
K870746 · Stanbio Laboratory · Jun 1987
RA SYSTEM, ANALYTE SERUM AMYLASE (30C AND 37C)
K871269 · Technicon Instruments Corp. · Apr 1987
AMYLASE COLORIMETRIC PROCEDURE
K864825 · Data Medical Associates, Inc. · Feb 1987
QKO (TM) AMYLASE B-HA
K864303 · Wako Chemicals USA, Inc. · Dec 1986
VISION(TM) AMYLASE
K864435 · Abbott Laboratories · Dec 1986
TDX(R) AMYLASE II
K863622 · Abbott Laboratories · Oct 1986