Cleared Traditional

K872730 - RESULT PLUS/HCG PREGNANCY TEST

K872730 is the FDA 510(k) clearance for RESULT PLUS/HCG PREGNANCY TEST by Ortho Diagnostic Systems, Inc.. It is a Class 2 Chemistry device (product code JHI) cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K872730 · Ortho Diagnostic Systems, Inc. · Chemistry device
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Oct 1987
Decision
104d
Days
Class 2
Risk

K872730 is an FDA 510(k) clearance for the RESULT PLUS/HCG PREGNANCY TEST. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Ortho Diagnostic Systems, Inc. (Raritan, US). The FDA issued a Cleared decision on October 20, 1987 after a review of 104 days - within the typical 510(k) review window.

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: 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 Ortho Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K872730 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1987
Decision Date October 20, 1987
Days to Decision 104 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
16d slower than avg
Panel avg: 88d · This submission: 104d
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 182
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K872730.
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
VENTRESCREEN, HCG URINE
K874258 · Ventrex Laboratories, Inc. · Nov 1987
AFFINITY HCG IMMUNIT (POLYCLONAL)
K873524 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1987
ALLEGRO(TM) HUMAN CHORIONIC GONADOTROPIN IM SYSTEM
K872390 · Nichols Institute Diagnostics · Sep 1987
ACCUPOINT HCG PREGNANCY TEST AND ACCESSORIES
K872130 · Syva Co. · Jul 1987