Cleared Traditional

K812461 - TANDEM QUALITATIVE HCG KIT

K812461 is the FDA 510(k) clearance for TANDEM QUALITATIVE HCG KIT by Hybritech, Inc.. It is a Class 2 Chemistry device (product code JHI) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K812461 · Hybritech, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1981
Decision
43d
Days
Class 2
Risk

K812461 is an FDA 510(k) clearance for the TANDEM QUALITATIVE HCG KIT. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Hybritech, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 13, 1981 after a review of 43 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 Hybritech, Inc. devices

Submission Details

510(k) Number K812461 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1981
Decision Date October 13, 1981
Days to Decision 43 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
45d faster than avg
Panel avg: 88d · This submission: 43d
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 K812461.
ROCHE B-HCG STANDARDS
K820614 · Hoffmann-La Roche, Inc. · Apr 1982
ABBOTT LABORATORIES B-HCG EIA
K820271 · Abbott Laboratories · Mar 1982
IMMOPHASE B HCG RADIOIMMUNOASSAY
K820321 · Corning Medical & Scientific · Mar 1982
CONCEP-7-BHCG
K812156 · Leeco Diagnostics, Inc. · Aug 1981
HCG RADIOIMMUNOASSAY KIT (125I)
K811421 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1981
HCG RADIOIMMUNOASSAY
K811116 · Hoffmann-La Roche, Inc. · May 1981