Cleared Traditional

K880933 - AMERLITE LH-30 ASSAY

K880933 is an FDA 510(k) clearance for AMERLITE LH-30 ASSAY, manufactured by Amersham Corp.. The device is a Class 1 Chemistry device with product code CEP cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K880933 · Amersham Corp. · Chemistry device
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Optimized for regulatory review, auditing and printing
Jul 1988
Decision
143d
Days
Class 1
Risk

K880933 is an FDA 510(k) clearance for the AMERLITE LH-30 ASSAY, LAN.0082/2082 240/144 TEST. Classified as Radioimmunoassay, Luteinizing Hormone (product code CEP), Class I - General Controls.

Submitted by Amersham Corp. (Arlington Heights, US). The FDA issued a Cleared decision on July 28, 1988 after a review of 143 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 Amersham Corp. devices

FDA 510(k) Submission Details - K880933

510(k) Number K880933 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1988
Decision Date July 28, 1988
Days to Decision 143 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
55d slower than avg
Panel avg: 88d · This submission: 143d
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 77
Devices cleared under the same product code (CEP) and FDA review panel - the closest regulatory comparables to K880933.
FIRST RESPONSE 10 MINUTE OVULATION PREDICTOR TEST
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K881124 · Nichols Institute Diagnostics · Apr 1988
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O.P.T.(TM) OVULATION PREDICTION TEST
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