Cleared Traditional

K935134 - ONE STEP LH TEST

K935134 is the FDA 510(k) clearance for ONE STEP LH TEST by Tcpi, Inc.. It is a Class 1 Chemistry device (product code CEP) cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K935134 · Tcpi, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1994
Decision
75d
Days
Class 1
Risk

K935134 is an FDA 510(k) clearance for the ONE STEP LH TEST. Classified as Radioimmunoassay, Luteinizing Hormone (product code CEP), Class I - General Controls.

Submitted by Tcpi, Inc. (Ft. Lauderdale, US). The FDA issued a Cleared decision on January 11, 1994 after a review of 75 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1485 - 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: 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 Tcpi, Inc. devices

Submission Details

510(k) Number K935134 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1993
Decision Date January 11, 1994
Days to Decision 75 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
13d faster than avg
Panel avg: 88d · This submission: 75d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CEP Radioimmunoassay, Luteinizing Hormone
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1485
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - CEP Radioimmunoassay, Luteinizing Hormone

All 68
Devices cleared under the same product code (CEP) and FDA review panel - the closest regulatory comparables to K935134.
CHEMILUMINESCENCE LH
K935319 · Nichols Institute Diagnostics · Apr 1995
SIMULTRAC LH/FSH RADIOUMMUNOASSAY KIT
K942638 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1994
ACCESS(R) HUMAN LUTEINZING HORMONE ASSAY
K940549 · Bio-Rad Laboratories, Inc. · Apr 1994
VISTA(R) HUMAN LUTEINIZING HORMONE(HLH) ASSAY
K926394 · Syva Co. · May 1993
COBAS CORE LH EIA
K930306 · Roche Diagnostic Systems, Inc. · May 1993
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM
K921176 · Vitek Systems, Inc. · Apr 1992