Cleared Traditional

K790376 - DUPONT ACA CKMB VERIFIERS

K790376 is the FDA 510(k) clearance for DUPONT ACA CKMB VERIFIERS by E.I. Dupont DE Nemours & Co., Inc.. It is a Class 1 Chemistry device (product code JJX) cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K790376 · E.I. Dupont DE Nemours & Co., Inc. · Chemistry device
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Apr 1979
Decision
40d
Days
Class 1
Risk

K790376 is an FDA 510(k) clearance for the DUPONT ACA CKMB VERIFIERS. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by E.I. Dupont DE Nemours & Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on April 4, 1979 after a review of 40 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 E.I. Dupont DE Nemours & Co., Inc. devices

Submission Details

510(k) Number K790376 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1979
Decision Date April 04, 1979
Days to Decision 40 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
48d faster than avg
Panel avg: 88d · This submission: 40d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJX Single (specified) Analyte 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 - JJX Single (specified) Analyte Controls (assayed And Unassayed)

All 370
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K790376.
BILIRUBIN CALIBRATOR CONTROL
K791141 · Beckman Instruments, Inc. · Aug 1979
NORMAL PROTEIN ELECTROPHORESIS CONTROL
K791029 · Beckman Instruments, Inc. · Jul 1979
ABNORMAL PROTEIN ELECTROPHORESIS CONTROL
K791031 · Beckman Instruments, Inc. · Jul 1979
SERUM PAK, HCG CONTROL
K790129 · Mallinckrodt Critical Care · Mar 1979
ACA LIPASE VERIFIERS
K772285 · E.I. Dupont DE Nemours & Co., Inc. · Jan 1978
ACA BILIRUBIN CALIBRATOR
K771798 · E.I. Dupont DE Nemours & Co., Inc. · Oct 1977