Cleared Traditional

K932768 - CARDIO REP CK CALIBRATORS 1 & 2 CAT. NO. 3322 & 3323

K932768 is an FDA 510(k) clearance for CARDIO REP CK CALIBRATORS 1 & 2 CAT. NO..., manufactured by Helena Laboratories. The device is a Class 2 Chemistry device with product code JIX cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K932768 · Helena Laboratories · Chemistry device
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Oct 1993
Decision
132d
Days
Class 2
Risk

K932768 is an FDA 510(k) clearance for the CARDIO REP CK CALIBRATORS 1 & 2 CAT. NO. 3322 & 3323. Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on October 18, 1993 after a review of 132 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Helena Laboratories devices

FDA 510(k) Submission Details - K932768

510(k) Number K932768 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1993
Decision Date October 18, 1993
Days to Decision 132 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 88d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JIX Device Classification - Class 2, Special Controls

Product Code JIX Calibrator, Multi-analyte Mixture
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
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 - JIX Calibrator, Multi-analyte Mixture

All 272
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