Cleared Traditional

K871420 - HERPES 1 AND 2 MICROASSAYS

K871420 is an FDA 510(k) clearance for HERPES 1 AND 2 MICROASSAYS, manufactured by Diamedix Corp.. The device is a Class 2 Microbiology device with product code GGC cleared through the Traditional 510(k) pathway after a 247-day FDA review.

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

FDA 510(k) Submission Details - K871420

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
Combination Product No
PCCP Authorized No
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.

GGC Device Classification - Class 2, Special Controls

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.

Regulatory Peers - GGC Control, Plasma, Abnormal

All 36
Devices cleared under the same product code (GGC) and FDA review panel - the closest regulatory comparables to K871420.
ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL II
K893971 · Analytical Control Systems, Inc. · Jul 1989
ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL III
K894338 · Analytical Control Systems, Inc. · Jul 1989
CLP ABNORMAL COAGULATION CONTROL
K881510 · Creative Laboratory Products, Inc. · May 1988
HPC TM (HEPARINIZED PLASMA CONTROL)
K770188 · Bio/Data Corp. · Feb 1977