Cleared Traditional

K913371 - TOTAL IRON AND UNSAT IRON BIND CAPAC/IR...

K913371 is the FDA 510(k) clearance for TOTAL IRON AND UNSAT IRON BIND CAPAC/IR... by Creative Laboratory Products, Inc.. It is a Class 2 Chemistry device (product code JIT) cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K913371 · Creative Laboratory Products, Inc. · Chemistry device
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Nov 1991
Decision
102d
Days
Class 2
Risk

K913371 is an FDA 510(k) clearance for the TOTAL IRON AND UNSAT IRON BIND CAPAC/IRON BIND CAL. Classified as Calibrator, Secondary (product code JIT), Class II - Special Controls.

Submitted by Creative Laboratory Products, Inc. (Indianapolis, US). The FDA issued a Cleared decision on November 8, 1991 after a review of 102 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 Creative Laboratory Products, Inc. devices

Submission Details

510(k) Number K913371 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1991
Decision Date November 08, 1991
Days to Decision 102 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 88d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIT Calibrator, Secondary
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 - JIT Calibrator, Secondary

All 160
Devices cleared under the same product code (JIT) and FDA review panel - the closest regulatory comparables to K913371.
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SECONDARY CALIBRATORS
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