Cleared Traditional

K013323 - TCI-31 LIFELONG OVULATION TESTER

K013323 is an FDA 510(k) clearance for TCI-31 LIFELONG OVULATION TESTER, manufactured by Tci New York. The device is a Class 1 Chemistry device with product code CEP cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K013323 · Tci New York · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2001
Decision
61d
Days
Class 1
Risk

K013323 is an FDA 510(k) clearance for the TCI-31 LIFELONG OVULATION TESTER. Classified as Radioimmunoassay, Luteinizing Hormone (product code CEP), Class I - General Controls.

Submitted by Tci New York (Los Angeles, US). The FDA issued a Cleared decision on December 5, 2001 after a review of 61 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 Tci New York devices

FDA 510(k) Submission Details - K013323

510(k) Number K013323 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 2001
Decision Date December 05, 2001
Days to Decision 61 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
27d faster than avg
Panel avg: 88d · This submission: 61d
Pathway characteristics
Predicate-based equivalence.

CEP Device Classification - Class 1, General Controls

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 102
Devices cleared under the same product code (CEP) and FDA review panel - the closest regulatory comparables to K013323.
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