Cleared Traditional

K881005 - IMMUCHEM HUMAN CHORIONIC GONADOTROPIN H...

K881005 is the FDA 510(k) clearance for IMMUCHEM HUMAN CHORIONIC GONADOTROPIN H... by Icn Biomedicals, Inc.. It is a Class 2 Chemistry device (product code JHI) cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K881005 · Icn Biomedicals, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1988
Decision
79d
Days
Class 2
Risk

K881005 is an FDA 510(k) clearance for the IMMUCHEM HUMAN CHORIONIC GONADOTROPIN HORMONE HCG. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Icn Biomedicals, Inc. (Carson, US). The FDA issued a Cleared decision on May 27, 1988 after a review of 79 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 Icn Biomedicals, Inc. devices

Submission Details

510(k) Number K881005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1988
Decision Date May 27, 1988
Days to Decision 79 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 88d · This submission: 79d
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 183
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K881005.
COTUBE HCG IRMA TEST
K882155 · Bio-Rad · Aug 1988
QTEST(TM) PREGNANCY
K882086 · Quidel Corp. · Jul 1988
AMERLITE HCG-60 ASSAY, LAN.0083/2083 240KIT/144KIT
K881355 · Amersham Corp. · Jun 1988
QUIDEL PREGNANCY TEST
K881595 · Quidel Corp. · May 1988
ABBOTT IMX HCG
K880070 · Abbott Laboratories · Mar 1988
CONCEP-7-BHCG
K880577 · Leeco Diagnostics, Inc. · Mar 1988