Cleared Traditional

K850730 - MODEL SERUM HCG ASSAY

K850730 is the FDA 510(k) clearance for MODEL SERUM HCG ASSAY by Monoclonal Antibodies, Inc.. It is a Class 2 Chemistry device (product code JHI) cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K850730 · Monoclonal Antibodies, Inc. · Chemistry device
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Apr 1985
Decision
39d
Days
Class 2
Risk

K850730 is an FDA 510(k) clearance for the MODEL SERUM HCG ASSAY. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Monoclonal Antibodies, Inc. (Mountain View, US). The FDA issued a Cleared decision on April 2, 1985 after a review of 39 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 Monoclonal Antibodies, Inc. devices

Submission Details

510(k) Number K850730 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 1985
Decision Date April 02, 1985
Days to Decision 39 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 88d · This submission: 39d
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 K850730.
LEECO CONCEP-7-BHCG IRMA
K850530 · Leeco Diagnostics, Inc. · Apr 1985
LEECO CONCEP-7-BHCG EIA
K850531 · Leeco Diagnostics, Inc. · Apr 1985
STRATUS HCG FLUOROMETRIC ENZYME IMMUNOASSAY
K850570 · American Dade · Apr 1985
TANDEM ICON HCG IMMUNOENZYMETRIC ASSAY KIT
K850159 · Hybritech, Inc. · Mar 1985
LEECO CONCEP-7-BHCG LEIAD II
K850201 · Leeco Diagnostics, Inc. · Mar 1985
CONCEP-7-BHCG (EIA)
K844153 · Leeco Diagnostics, Inc. · Dec 1984