Cleared Traditional

DELTA TEST AMYLASE UV (K800049) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K800049 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Chemistry device
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Jan 1980
Decision
14d
Days
Class 2
Risk

K800049 is an FDA 510(k) clearance for the DELTA TEST AMYLASE UV. Classified as Catalytic Methods, Amylase (product code JFJ), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on January 23, 1980 after a review of 14 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K800049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 1980
Decision Date January 23, 1980
Days to Decision 14 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
74d faster than avg
Panel avg: 88d · This submission: 14d
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 38
Devices cleared under the same product code (JFJ) and FDA review panel - the closest regulatory comparables to K800049.
PARAMAX AMALINE REAGENT
K831536 · American Dade · Jun 1983
SINGLE VIAL AMYLASE PNP TEST
K823462 · Boehringer Mannheim Corp. · Dec 1982
BEKCMAN ASTRA SYSTEMS AMYLASE CHEMISTRY
K802581 · Beckman Instruments, Inc. · Nov 1980
MULTISTAT III, AMYLASE TEST
K771622 · Instrumentation Laboratory CO · Sep 1977
REAGENT KIT, ENZYMATIC AMYLASE
K770750 · Beckman Instruments, Inc. · Jul 1977