Cleared Traditional

K883530 - FIRST RESPONSE 10 MINUTE OVULATION PREDICTOR TEST

K883530 is an FDA 510(k) clearance for FIRST RESPONSE 10 MINUTE OVULATION PRED..., manufactured by Tambrands, Inc.. The device is a Class 1 Chemistry device with 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

FDA 510(k) Submission Details - K883530

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.

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 101
Devices cleared under the same product code (CEP) and FDA review panel - the closest regulatory comparables to K883530.
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PHASE II LH KIT
K882252 · Vitek Systems, Inc. · Aug 1988