Cleared Traditional

TREP CARD EIKEN (K820567) - FDA 510(k) Clearance

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

K820567 · Syn-Kit, Inc. · Microbiology device
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Apr 1982
Decision
43d
Days
Class 2
Risk

K820567 is an FDA 510(k) clearance for the TREP CARD EIKEN. Classified as Antigens, Nontreponemal, All (product code GMQ), Class II - Special Controls.

Submitted by Syn-Kit, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 14, 1982 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3820 - the FDA microbiology 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 Syn-Kit, Inc. devices

Submission Details

510(k) Number K820567 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1982
Decision Date April 14, 1982
Days to Decision 43 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 102d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GMQ Antigens, Nontreponemal, All
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3820
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 Microbiology devices follow this clearance model.

Regulatory Peers - GMQ Antigens, Nontreponemal, All

All 31
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