Cleared Traditional

K831366 - TESTCORP PREG

K831366 is an FDA 510(k) clearance for TESTCORP PREG, manufactured by Catheter Technology Corp.. The device is a Class 2 Microbiology device with product code JHJ cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K831366 · Catheter Technology Corp. · Microbiology device
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Jun 1983
Decision
37d
Days
Class 2
Risk

K831366 is an FDA 510(k) clearance for the TESTCORP PREG. Classified as Agglutination Method, Human Chorionic Gonadotropin (product code JHJ), Class II - Special Controls.

Submitted by Catheter Technology Corp. (Walker, US). The FDA issued a Cleared decision on June 2, 1983 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 862.1155 - 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 Catheter Technology Corp. devices

FDA 510(k) Submission Details - K831366

510(k) Number K831366 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1983
Decision Date June 02, 1983
Days to Decision 37 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 102d · This submission: 37d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JHJ Device Classification - Class 2, Special Controls

Product Code JHJ Agglutination Method, Human Chorionic Gonadotropin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1155
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 - JHJ Agglutination Method, Human Chorionic Gonadotropin

All 55
Devices cleared under the same product code (JHJ) and FDA review panel - the closest regulatory comparables to K831366.
HCG-CHECK
K831466 · Diagnostic Technology, Inc. · Jun 1983
B HCG-CHECK
K831468 · Diagnostic Technology, Inc. · Jun 1983
NEO-PREGNOSTICON DUOCLON TUBE TEST
K831339 · Organon, Inc. · Jun 1983
BETA FFIRM TEST
K823682 · Organon, Inc. · Jan 1983
PREG/TEX PREGNANCY TEST
K821387 · Texas Immunology, Inc. · Jun 1982
ACCURATE BETA
K812967 · Organon, Inc. · Nov 1981