Cleared Traditional

K964461 - ONE -STEP URINE/SERUM COMBO PREGNANCY C...

K964461 is an FDA 510(k) clearance for ONE -STEP URINE/SERUM COMBO PREGNANCY C..., 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 96-day FDA review.

K964461 · Teco Diagnostics · Chemistry device
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Feb 1997
Decision
96d
Days
Class 2
Risk

K964461 is an FDA 510(k) clearance for the ONE -STEP URINE/SERUM COMBO PREGNANCY CARD TEST. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Teco Diagnostics (Anaheim, US). The FDA issued a Cleared decision on February 11, 1997 after a review of 96 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 - K964461

510(k) Number K964461 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1996
Decision Date February 11, 1997
Days to Decision 96 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
8d slower than avg
Panel avg: 88d · This submission: 96d
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 K964461.
CARDS Q.S. HCG-URINE
K972748 · Quidel Corp. · Aug 1997
CLINITEK HCG TEST STRIPS
K971209 · Bayer Corp. · Apr 1997
ABBOTT TESTPACK PLUS HCG COMBO WITH OBC
K965116 · Abbott Laboratories · Feb 1997
ONE-STEP URINE/SERUM COMNO PREGNANCY DIPSTICK TEST
K964462 · Teco Diagnostics · Feb 1997
ONE-STEP DIPSTICK PREGNANCY TEST
K964536 · Teco Diagnostics · Feb 1997
SAS ONE-STEP PREGNANCY
K964995 · Sa Scientific, Inc. · Jan 1997