Cleared Traditional

FLUORESCENT TREPONEMEL ANTIBODY-ABSORB (K843613) - FDA 510(k) Clearance

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K843613 · Immuno-Products Industries · Immunology device
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Oct 1984
Decision
51d
Days
Class 2
Risk

K843613 is an FDA 510(k) clearance for the FLUORESCENT TREPONEMEL ANTIBODY-ABSORB. Classified as Anti-human Globulin, Fta-abs Test (product code GMS), Class II - Special Controls.

Submitted by Immuno-Products Industries (So. Bound Brook, US). The FDA issued a Cleared decision on October 31, 1984 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.3830 - the FDA immunology device 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 Immuno-Products Industries devices

Submission Details

510(k) Number K843613 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 1984
Decision Date October 31, 1984
Days to Decision 51 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 104d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GMS Anti-human Globulin, Fta-abs Test
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3830
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 Immunology devices follow this clearance model.