Cleared Traditional

K781100 - DELTA TEST AMYLASE/LIPASE CONTS. I

K781100 is the FDA 510(k) clearance for DELTA TEST AMYLASE/LIPASE CONTS. I by Bd Becton Dickinson Vacutainer Systems Preanalytic. It is a Class 1 Chemistry device (product code JJT) cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K781100 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Chemistry device
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Optimized for regulatory review, auditing and printing
Aug 1978
Decision
42d
Days
Class 1
Risk

K781100 is an FDA 510(k) clearance for the DELTA TEST AMYLASE/LIPASE CONTS. I,II. Classified as Enzyme Controls (assayed And Unassayed) (product code JJT), Class I - General Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on August 14, 1978 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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 K781100 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1978
Decision Date August 14, 1978
Days to Decision 42 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
46d faster than avg
Panel avg: 88d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJT Enzyme Controls (assayed And Unassayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JJT Enzyme Controls (assayed And Unassayed)

All 60
Devices cleared under the same product code (JJT) and FDA review panel - the closest regulatory comparables to K781100.
CK ISOENZYME ELECTROPHORESIS CONTROL-I.D
K800604 · Beckman Instruments, Inc. · Apr 1980
QUANTAFFIRM CPK ISO ENZYME SERUM (HUMAN)
K791723 · Organon, Inc. · Oct 1979
P.A.P. RIA CONTROL SERUM PACK
K790985 · Mallinckrodt Critical Care · Jul 1979
ISOZYME - ID CPK MARKER
K780801 · Dade, Baxter Travenol Diagnostics, Inc. · Jun 1978
CLIN. CHEM. CONTROL SERUM-QUANTITATE
K780554 · Beckman Instruments, Inc. · Jun 1978
CHEMISTRY CONTROL & REFERENCE SERUMS
K780204 · Hyland Therapeutic Div., Travenol Laboratories · Mar 1978