Cleared Traditional

K955353 - ONE STEP PREGNANCY HCG SERUN DILUENT REAGENT

K955353 is an FDA 510(k) clearance for ONE STEP PREGNANCY HCG SERUN DILUENT RE..., manufactured by Tcpi, Inc.. 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.

K955353 · Tcpi, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K955353

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
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 287
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K955353.
DSL ACTIVE I-HCG ELISA
K961911 · Diagnostic Systems Laboratories, Inc. · Jun 1996
DSL ACTIVE I-HCG IRMA
K960357 · Diagnostic Systems Laboratories, Inc. · May 1996
BIONIKE A/Q PREGNANCY TEST
K960992 · Bionike Laboratories, Inc. · Apr 1996
ACCUSTAT HCG SERUM DILUENT REAGENT OR EVENT SERUM DILUENT
K955266 · Boehringer Mannheim Italia Spa · Feb 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