Cleared Traditional

K873033 - HCG SEROZYME IMMUNOENZYM ASSAY KIT/MAG ...

K873033 is the FDA 510(k) clearance for HCG SEROZYME IMMUNOENZYM ASSAY KIT/MAG ... by Serono Diagnostics, Inc.. It is a Class 2 Immunology device (product code JHI) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K873033 · Serono Diagnostics, Inc. · Immunology device
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Sep 1987
Decision
41d
Days
Class 2
Risk

K873033 is an FDA 510(k) clearance for the HCG SEROZYME IMMUNOENZYM ASSAY KIT/MAG SOLID PHASE. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Serono Diagnostics, Inc. (Norwell, US). The FDA issued a Cleared decision on September 14, 1987 after a review of 41 days - a notably fast clearance cycle.

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: 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 Serono Diagnostics, Inc. devices

Submission Details

510(k) Number K873033 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1987
Decision Date September 14, 1987
Days to Decision 41 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 104d · This submission: 41d
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 Immunology 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 K873033.
VENTRESCREEN, HCG URINE
K874258 · Ventrex Laboratories, Inc. · Nov 1987
RESULT PLUS/HCG PREGNANCY TEST
K872730 · Ortho Diagnostic Systems, Inc. · Oct 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
HCG MAB SOLID PHASE COMPONENT SYSTEM
K871700 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1987