Cleared Traditional

K955353 - ONE STEP PREGNANCY HCG SERUN DILUENT RE...

K955353 is the FDA 510(k) clearance for ONE STEP PREGNANCY HCG SERUN DILUENT RE... by Tcpi, Inc.. It is a Class 2 Chemistry device (product code JHI) cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K955353 · Tcpi, Inc. · Chemistry device
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Mar 1996
Decision
119d
Days
Class 2
Risk

K955353 is an FDA 510(k) clearance for the ONE STEP PREGNANCY HCG SERUN DILUENT REAGENT. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Tcpi, Inc. (Pompano Beach, US). The FDA issued a Cleared decision on March 19, 1996 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 Tcpi, Inc. devices

Submission Details

510(k) Number K955353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1995
Decision Date March 19, 1996
Days to Decision 119 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
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.

Device Classification

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 183
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K955353.
SAS ONE-STEP PREGNANCY
K964995 · Sa Scientific, Inc. · Jan 1997
DSL ACTIVE I-HCG ELISA
K961911 · Diagnostic Systems Laboratories, Inc. · Jun 1996
DSL ACTIVE I-HCG IRMA
K960357 · Diagnostic Systems Laboratories, Inc. · May 1996
ACCESS TOTAL BHCG ASSAY (MODIFICATION)
K954732 · Bio-Rad Laboratories, Inc. · Nov 1995
CARDS Q.S. HCG OR CONCISE PERFORMANCE PLUS HCG
K954273 · Quidel Corp. · Oct 1995
TESTPACK PLUS HCG URINE
K954029 · Abbott Laboratories · Oct 1995