Cleared Traditional

HERPES 1 AND 2 MICROASSAYS (K871420) - FDA 510(k) Clearance

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

K871420 · Diamedix Corp. · Microbiology device
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Dec 1987
Decision
247d
Days
Class 2
Risk

K871420 is an FDA 510(k) clearance for the HERPES 1 AND 2 MICROASSAYS. Classified as Control, Plasma, Abnormal (product code GGC), Class II - Special Controls.

Submitted by Diamedix Corp. (Miami, US). The FDA issued a Cleared decision on December 11, 1987 after a review of 247 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 864.5425 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Diamedix Corp. devices

Submission Details

510(k) Number K871420 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1987
Decision Date December 11, 1987
Days to Decision 247 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
145d slower than avg
Panel avg: 102d · This submission: 247d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GGC Control, Plasma, Abnormal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5425
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.