Cleared Traditional

K801244 - ROCHE HCG STANDARDS

K801244 is an FDA 510(k) clearance for ROCHE HCG STANDARDS, 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 24-day FDA review.

K801244 · Hoffmann-La Roche, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1980
Decision
24d
Days
Class 2
Risk

K801244 is an FDA 510(k) clearance for the ROCHE HCG STANDARDS. 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 June 20, 1980 after a review of 24 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 - K801244

510(k) Number K801244 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 1980
Decision Date June 20, 1980
Days to Decision 24 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
64d faster than avg
Panel avg: 88d · This submission: 24d
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 K801244.
DAC-CEL DIAGNATAL
K810214 · Burroughs Wellcome Co. · Mar 1981
BETA-TEC QUALITATIVE
K802999 · Armkel, LLC · Dec 1980
GAMMADAB B-HCG RADIOIMMUNOASSAY KIT
K801409 · Travenol Laboratories, S.A. · Jul 1980
HUMAN CHORIONIC GONADOTROPIN (RIA)
K792197 · Nuclear Medical Laboratories, Inc. · Dec 1979
CONCEP-7-BHCG
K792308 · Leeco Diagnostics, Inc. · Dec 1979
HCG RIA PREGNANCY TEST
K791206 · Hoffmann-La Roche, Inc. · Jul 1979