Cleared Traditional

K890819 - HSV-CHECK(TM) TEST KIT

K890819 is an FDA 510(k) clearance for HSV-CHECK(TM) TEST KIT, manufactured by Diagnostic Technology, Inc.. The device is a Class 2 Microbiology device with product code HIS cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K890819 · Diagnostic Technology, Inc. · Microbiology device
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Jun 1989
Decision
123d
Days
Class 2
Risk

K890819 is an FDA 510(k) clearance for the HSV-CHECK(TM) TEST KIT. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Diagnostic Technology, Inc. (Hauppauge, US). The FDA issued a Cleared decision on June 20, 1989 after a review of 123 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 884.5300 - 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 Diagnostic Technology, Inc. devices

FDA 510(k) Submission Details - K890819

510(k) Number K890819 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 1989
Decision Date June 20, 1989
Days to Decision 123 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
21d slower than avg
Panel avg: 102d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HIS Device Classification - Class 2, Special Controls

Product Code HIS Condom
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5300
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 - HIS Condom

All 59
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K890819.
NUDA (CURRENTLY CALLED ULTRA SENSITIVE)
K901111 · Ansell, Inc. · Mar 1990
G.S.A. COLORED CONDOMS
K901112 · Ansell, Inc. · Mar 1990
MAGNUM PLUS LATEX CONDOM W/SPERMICIDAL LUBRICANT
K895640 · Armkel, LLC · Jan 1990
TROJAN FOR WOMEN
K890863 · Armkel, LLC · Apr 1989
KISS OF MINT(TM) NON-LUBRICATED CONDOM
K882389 · Ansell, Inc. · Oct 1988
LIFESTYLES EXTRA STRENGTH CONDOMS W/NONOXYNOL-9
K871304 · Ansell, Inc. · Jun 1987