Cleared Traditional

K771740 - CARDIOZYME CK-CONTROL LEVEL 1

K771740 is the FDA 510(k) clearance for CARDIOZYME CK-CONTROL LEVEL 1 by Dade, Baxter Travenol Diagnostics, Inc.. It is a Class 1 Chemistry device (product code JJT) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K771740 · Dade, Baxter Travenol Diagnostics, Inc. · Chemistry device
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Oct 1977
Decision
34d
Days
Class 1
Risk

K771740 is an FDA 510(k) clearance for the CARDIOZYME CK-CONTROL LEVEL 1. Classified as Enzyme Controls (assayed And Unassayed) (product code JJT), Class I - General Controls.

Submitted by Dade, Baxter Travenol Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 19, 1977 after a review of 34 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 Dade, Baxter Travenol Diagnostics, Inc. devices

Submission Details

510(k) Number K771740 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1977
Decision Date October 19, 1977
Days to Decision 34 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
54d faster than avg
Panel avg: 88d · This submission: 34d
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 58
Devices cleared under the same product code (JJT) and FDA review panel - the closest regulatory comparables to K771740.
CHEMISTRY CONTROL & REFERENCE SERUMS
K780204 · Hyland Therapeutic Div., Travenol Laboratories · Mar 1978
ISOENZYME SERUM CONTROL
K780147 · Corning Medical & Scientific · Feb 1978
ACA GLUTAMYL TRANSFERASE
K771800 · E.I. Dupont DE Nemours & Co., Inc. · Oct 1977
CARDIOZYME CK-CONTROL ABNORMAL
K770971 · Dade, Baxter Travenol Diagnostics, Inc. · Aug 1977
CARDIOZYME CK CONTROL NORMAL
K770973 · Dade, Baxter Travenol Diagnostics, Inc. · Aug 1977
LDH ISOTROL T
K770049 · Sigma Chemical Co. · Jan 1977