Cleared Traditional

K936031 - ONE STEP PREGNANCY TEST

K936031 is an FDA 510(k) clearance for ONE STEP PREGNANCY TEST, manufactured by Teco Diagnostics. The device is a Class 2 Chemistry device with product code JHI cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K936031 · Teco Diagnostics · Chemistry device
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Apr 1994
Decision
119d
Days
Class 2
Risk

K936031 is an FDA 510(k) clearance for the ONE STEP PREGNANCY TEST. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Teco Diagnostics (Placentia, US). The FDA issued a Cleared decision on April 15, 1994 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1155 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Teco Diagnostics devices

FDA 510(k) Submission Details - K936031

510(k) Number K936031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1993
Decision Date April 15, 1994
Days to Decision 119 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 88d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JHI Device Classification - Class 2, Special Controls

Product Code JHI Visual, Pregnancy Hcg, Prescription Use
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 Chemistry devices follow this clearance model.

Regulatory Peers - JHI Visual, Pregnancy Hcg, Prescription Use

All 232
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K936031.
RAPIDVUE(TM) HCG
K945969 · Quidel Corp. · Jan 1995
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AXSYM TOTAL B-HCG
K935673 · Abbott Laboratories · Jun 1994
KODAK SURECELL HCG-SERUM/URINE TEST KIT, MODIFICATION
K936138 · Eastman Kodak Company · Apr 1994
KODAK SURECELL HCG URINE TEST, MODIFICATION
K936287 · Eastman Kodak Company · Apr 1994
MEDIX BIOTECH BESTEST HCG-URINE TEST KIT
K932758 · Medix Biotech, Inc. · Sep 1993