Cleared Traditional

K820822 - TANDEM HCG KIT

K820822 is the FDA 510(k) clearance for TANDEM HCG KIT by Hybritech, Inc.. It is a Class 2 Chemistry device (product code JHI) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K820822 · Hybritech, Inc. · Chemistry device
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Apr 1982
Decision
36d
Days
Class 2
Risk

K820822 is an FDA 510(k) clearance for the TANDEM 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 April 29, 1982 after a review of 36 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 K820822 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1982
Decision Date April 29, 1982
Days to Decision 36 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
52d faster than avg
Panel avg: 88d · This submission: 36d
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 K820822.
TANDEM HCG IMMUNOEZYMETRIC ASSAY KIT
K821944 · Hybritech, Inc. · Jul 1982
ROCHE(R) B-HCG RIA URINE STANDARD
K820942 · Hoffmann-La Roche, Inc. · May 1982
AMERLEX B-LCG RIA KIT
K821031 · Amersham Corp. · May 1982
ROCHE B-HCG RIA
K820613 · Hoffmann-La Roche, Inc. · Apr 1982
ROCHE B-HCG STANDARDS
K820614 · Hoffmann-La Roche, Inc. · Apr 1982
ABBOTT LABORATORIES B-HCG EIA
K820271 · Abbott Laboratories · Mar 1982