Cleared Traditional

K033786 - LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF TESTOSTERONE IN SERUM AND SALIVA

K033786 is an FDA 510(k) clearance for LUMINESCENT IMMUNOASSAY KIT FOR THE DET..., manufactured by Ibl GmbH. The device is a Class 2 Chemistry device with product code JIT cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K033786 · Ibl GmbH · Chemistry device
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Feb 2004
Decision
85d
Days
Class 2
Risk

K033786 is an FDA 510(k) clearance for the LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF TESTOSTERONE IN SERUM AND SA.... Classified as Calibrator, Secondary (product code JIT), Class II - Special Controls.

Submitted by Ibl GmbH (East Stroudsburg, US). The FDA issued a Cleared decision on February 27, 2004 after a review of 85 days - a notably fast clearance cycle.

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: 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 Ibl GmbH devices

FDA 510(k) Submission Details - K033786

510(k) Number K033786 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2003
Decision Date February 27, 2004
Days to Decision 85 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
3d faster than avg
Panel avg: 88d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JIT Device Classification - Class 2, Special Controls

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 209
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