Cleared Traditional

K874033 - IRMA-COUNT HCG W/MONO. ANTIBODIES RKCG1,5,X

K874033 is an FDA 510(k) clearance for IRMA-COUNT HCG W/MONO. ANTIBODIES RKCG1, manufactured by Diagnostic Products Corp.. The device is a Class 2 Immunology device with product code JHI cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K874033 · Diagnostic Products Corp. · Immunology device
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Jan 1988
Decision
95d
Days
Class 2
Risk

K874033 is an FDA 510(k) clearance for the IRMA-COUNT HCG W/MONO. ANTIBODIES RKCG1,5,X. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on January 5, 1988 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1155 - the FDA immunology device 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 Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Diagnostic Products Corp. devices

FDA 510(k) Submission Details - K874033

510(k) Number K874033 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1987
Decision Date January 05, 1988
Days to Decision 95 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 105d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JHI Device Classification - Class 2, Special Controls

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 Immunology devices follow this clearance model.

Regulatory Peers - JHI Visual, Pregnancy Hcg, Prescription Use

All 282
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K874033.
ABBOTT IMX HCG
K880070 · Abbott Laboratories · Mar 1988
CONCEP-7-BHCG
K880577 · Leeco Diagnostics, Inc. · Mar 1988
KODAK SURECELL(TM) HCG-URINE KIT
K874388 · Eastman Kodak Company · Feb 1988
CARDS(TM) HCG-SERUM/URINE CR-7503 AND CR-7504
K873788 · Pacific Biotech, Inc. · Nov 1987
VENTRESCREEN, HCG URINE
K874258 · Ventrex Laboratories, Inc. · Nov 1987
RESULT PLUS/HCG PREGNANCY TEST
K872730 · Ortho Diagnostic Systems, Inc. · Oct 1987