Cleared Traditional

K881435 - PREGNOSPIA II

K881435 is an FDA 510(k) clearance for PREGNOSPIA II, manufactured by Organon Teknika Corp.. The device is a Class 2 Chemistry device with product code JHJ cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K881435 · Organon Teknika Corp. · Chemistry device
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May 1988
Decision
52d
Days
Class 2
Risk

K881435 is an FDA 510(k) clearance for the PREGNOSPIA II. Classified as Agglutination Method, Human Chorionic Gonadotropin (product code JHJ), Class II - Special Controls.

Submitted by Organon Teknika Corp. (Durham, US). The FDA issued a Cleared decision on May 27, 1988 after a review of 52 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 Organon Teknika Corp. devices

FDA 510(k) Submission Details - K881435

510(k) Number K881435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1988
Decision Date May 27, 1988
Days to Decision 52 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
36d faster than avg
Panel avg: 88d · This submission: 52d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JHJ Device Classification - Class 2, Special Controls

Product Code JHJ Agglutination Method, Human Chorionic Gonadotropin
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 - JHJ Agglutination Method, Human Chorionic Gonadotropin

All 51
Devices cleared under the same product code (JHJ) and FDA review panel - the closest regulatory comparables to K881435.
SAS(TM) MONOCLONAL HCG-SLIDE
K930609 · Sa Scientific, Inc. · Mar 1993
DIRECT PREGNANCY TEST
K920716 · Tech-Co, Inc. · Mar 1992
CLEARVIEW HCG
K910946 · Unipath , Ltd. · Apr 1991
HCG-NOSTICK
K880328 · Organon Teknika Corp. · Mar 1988
V-TREND BETA-HCG DRY-SPOT TEST
K875262 · Texas Immunology, Inc. · Feb 1988
V-TREND BETA-HCG TEST
K874638 · Texas Immunology, Inc. · Jan 1988