Cleared Traditional

K883530 - FIRST RESPONSE 10 MINUTE OVULATION PRED...

K883530 is the FDA 510(k) clearance for FIRST RESPONSE 10 MINUTE OVULATION PRED... by Tambrands, Inc.. It is a Class 1 Chemistry device (product code CEP) cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K883530 · Tambrands, Inc. · Chemistry device
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Dec 1988
Decision
123d
Days
Class 1
Risk

K883530 is an FDA 510(k) clearance for the FIRST RESPONSE 10 MINUTE OVULATION PREDICTOR TEST. Classified as Radioimmunoassay, Luteinizing Hormone (product code CEP), Class I - General Controls.

Submitted by Tambrands, Inc. (Palmer, US). The FDA issued a Cleared decision on December 19, 1988 after a review of 123 days - within the typical 510(k) review window.

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: 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 Tambrands, Inc. devices

Submission Details

510(k) Number K883530 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1988
Decision Date December 19, 1988
Days to Decision 123 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 88d · This submission: 123d
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 67
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