Cleared Traditional

AMERLITE HCG-60 ASSAY, LAN.0083/2083 240KIT/144KIT (K881355) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K881355 · Amersham Corp. · Chemistry device
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Jun 1988
Decision
51d
Days
Class 2
Risk

K881355 is an FDA 510(k) clearance for the AMERLITE HCG-60 ASSAY, LAN.0083/2083 240KIT/144KIT. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Amersham Corp. (Arlington Heights, US). The FDA issued a Cleared decision on June 8, 1988 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1155 - 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 Amersham Corp. devices

Submission Details

510(k) Number K881355 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 1988
Decision Date June 08, 1988
Days to Decision 51 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 88d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JHI Visual, Pregnancy Hcg, Prescription Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1155
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - JHI Visual, Pregnancy Hcg, Prescription Use

All 60
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K881355.
IMX TOTAL B-HCG
K894182 · Abbott Laboratories · Sep 1989
ABBOTT TESTPACK PLUS HCG URINE
K894408 · Abbott Laboratories · Sep 1989
COTUBE HCG IRMA TEST
K882155 · Bio-Rad · Aug 1988
ABBOTT IMX HCG
K880070 · Abbott Laboratories · Mar 1988
KODAK SURECELL(TM) HCG-URINE KIT
K874388 · Eastman Kodak Company · Feb 1988
IRMA-COUNT HCG W/MONO. ANTIBODIES RKCG1,5,X
K874033 · Diagnostic Products Corp. · Jan 1988