Cleared Traditional

K791206 - HCG RIA PREGNANCY TEST

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

K791206 · Hoffmann-La Roche, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K791206

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.

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 Chemistry devices follow this clearance model.

Regulatory Peers - JHI Visual, Pregnancy Hcg, Prescription Use

All 289
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K791206.
ROCHE HCG STANDARDS
K801244 · Hoffmann-La Roche, Inc. · Jun 1980
HUMAN CHORIONIC GONADOTROPIN (RIA)
K792197 · Nuclear Medical Laboratories, Inc. · Dec 1979
CONCEP-7-BHCG
K792308 · Leeco Diagnostics, Inc. · Dec 1979
HUMAN CHORIONIC GONADOTROPHIN STANDARDS
K790863 · Pcl-Ria, Inc. · Jul 1979
RABBIT ANTISERUM TO HUMAN CHORIONIC
K790864 · Pcl-Ria, Inc. · Jul 1979
LABELED HUMAN CHORIONIC GONADOTROPHIN
K790876 · Pcl-Ria, Inc. · Jul 1979