Cleared Traditional

K840328 - PHASE II HCG KIT

K840328 is the FDA 510(k) clearance for PHASE II HCG KIT by Medical & Scientific Designs, Inc.. It is a Class 2 Chemistry device (product code JHI) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K840328 · Medical & Scientific Designs, Inc. · Chemistry device
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Apr 1984
Decision
85d
Days
Class 2
Risk

K840328 is an FDA 510(k) clearance for the PHASE II HCG KIT. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Medical & Scientific Designs, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 19, 1984 after a review of 85 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 Medical & Scientific Designs, Inc. devices

Submission Details

510(k) Number K840328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1984
Decision Date April 19, 1984
Days to Decision 85 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 88d · This submission: 85d
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 K840328.
OREIA II B-HCG PREGNANCY TEST KIT
K841525 · Organon, Inc. · Jun 1984
VENTREZYME BETA-HCG IMMUNOASSAY HCG
K841081 · Ventrex Laboratories, Inc. · May 1984
COATED TUBE HCG IMMUNOASSAY HCG
K841023 · Ventrex Laboratories, Inc. · May 1984
TANDEM VISUAL HCG IMMUNOENZYMETRIC
K834000 · Hybritech, Inc. · Feb 1984
TANDEM R-TOTAL B-GCG KIT
K833194 · Hybritech, Inc. · Jan 1984
OREIA II B-HCG, ENZYME INNUNOASSAY
K832801 · Organon, Inc. · Dec 1983