Cleared Traditional

K791206 - HCG RIA PREGNANCY TEST

K791206 is the FDA 510(k) clearance for HCG RIA PREGNANCY TEST by Hoffmann-La Roche, Inc.. It is a Class 2 Chemistry device (product code JHI) cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K791206 · Hoffmann-La Roche, Inc. · Chemistry device
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Jul 1979
Decision
31d
Days
Class 2
Risk

K791206 is an FDA 510(k) clearance for the HCG RIA PREGNANCY TEST. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Hoffmann-La Roche, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 30, 1979 after a review of 31 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 Hoffmann-La Roche, Inc. devices

Submission Details

510(k) Number K791206 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 1979
Decision Date July 30, 1979
Days to Decision 31 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
57d faster than avg
Panel avg: 88d · This submission: 31d
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 K791206.
GAMMADAB B-HCG RADIOIMMUNOASSAY KIT
K801409 · Travenol Laboratories, S.A. · Jul 1980
ROCHE HCG STANDARDS
K801244 · Hoffmann-La Roche, Inc. · Jun 1980
CONCEP-7-BHCG
K792308 · Leeco Diagnostics, Inc. · Dec 1979
CONCEP-7-B-HCG
K790397 · Leeco Diagnostics, Inc. · May 1979
RIA QUANT B-HCG TEST KIT
K781578 · Mallinckrodt Critical Care · Oct 1978
QUANTROLS HCG
K772086 · Organon, Inc. · Nov 1977