Cleared Traditional

K803169 - CARDIOZYME PLUS CK-TOTAL #65046

K803169 is an FDA 510(k) clearance for CARDIOZYME PLUS CK-TOTAL #65046, manufactured by Harleco. The device is a Class 2 Chemistry device with product code JHS cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K803169 · Harleco · Chemistry device
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Jan 1981
Decision
25d
Days
Class 2
Risk

K803169 is an FDA 510(k) clearance for the CARDIOZYME PLUS CK-TOTAL #65046. Classified as Differential Rate Kinetic Method, Cpk Or Isoenzymes (product code JHS), Class II - Special Controls.

Submitted by Harleco (Mchenry, US). The FDA issued a Cleared decision on January 9, 1981 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1215 - 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 Harleco devices

FDA 510(k) Submission Details - K803169

510(k) Number K803169 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1980
Decision Date January 09, 1981
Days to Decision 25 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
63d faster than avg
Panel avg: 88d · This submission: 25d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JHS Device Classification - Class 2, Special Controls

Product Code JHS Differential Rate Kinetic Method, Cpk Or Isoenzymes
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1215
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 - JHS Differential Rate Kinetic Method, Cpk Or Isoenzymes

All 34
Devices cleared under the same product code (JHS) and FDA review panel - the closest regulatory comparables to K803169.
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDDE
K820722 · Eastman Kodak Company · Apr 1982
CPK(CK) IN VITRO DIAG. REAGENT SET
K813406 · Pointe Scientific, Inc., · Dec 1981
WORTHINGTON CK (NAC) REAGENT SET
K810997 · Worthington Diagnostic Systems · Apr 1981
CK-MB(IMMUNOLOGICAL)
K802521 · Biodynamics Corp. · Nov 1980
WORTHINGTON FLOZYME* CPK (340NM)
K800028 · Worthington Diagnostic Systems · Jan 1980
ESKACHEM, CK-MB REAGENT
K792023 · Smithkline Diagnostics, Inc. · Oct 1979