Cleared Traditional

K790397 - CONCEP-7-B-HCG

K790397 is the FDA 510(k) clearance for CONCEP-7-B-HCG by Leeco Diagnostics, Inc.. It is a Class 2 Chemistry device (product code JHI) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K790397 · Leeco Diagnostics, Inc. · Chemistry device
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May 1979
Decision
86d
Days
Class 2
Risk

K790397 is an FDA 510(k) clearance for the CONCEP-7-B-HCG. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Leeco Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 23, 1979 after a review of 86 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 Leeco Diagnostics, Inc. devices

Submission Details

510(k) Number K790397 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1979
Decision Date May 23, 1979
Days to Decision 86 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
2d faster than avg
Panel avg: 88d · This submission: 86d
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 K790397.
ROCHE HCG STANDARDS
K801244 · Hoffmann-La Roche, Inc. · Jun 1980
CONCEP-7-BHCG
K792308 · Leeco Diagnostics, Inc. · Dec 1979
HCG RIA PREGNANCY TEST
K791206 · Hoffmann-La Roche, Inc. · Jul 1979
RIA QUANT B-HCG TEST KIT
K781578 · Mallinckrodt Critical Care · Oct 1978
QUANTROLS HCG
K772086 · Organon, Inc. · Nov 1977