Cleared Traditional

K781794 - BETA-TEC

K781794 is an FDA 510(k) clearance for BETA-TEC, manufactured by Wampole Laboratories. The device is a Class 2 Immunology device with product code JHI cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K781794 · Wampole Laboratories · Immunology device
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Dec 1978
Decision
65d
Days
Class 2
Risk

K781794 is an FDA 510(k) clearance for the BETA-TEC. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Wampole Laboratories (Mchenry, US). The FDA issued a Cleared decision on December 29, 1978 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1155 - the FDA immunology device 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 Wampole Laboratories devices

FDA 510(k) Submission Details - K781794

510(k) Number K781794 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1978
Decision Date December 29, 1978
Days to Decision 65 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 105d · This submission: 65d
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 Immunology devices follow this clearance model.

Regulatory Peers - JHI Visual, Pregnancy Hcg, Prescription Use

All 294
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K781794.
LABELED HUMAN CHORIONIC GONADOTROPHIN
K790876 · Pcl-Ria, Inc. · Jul 1979
CONCEP-7-B-HCG
K790397 · Leeco Diagnostics, Inc. · May 1979
CHORIC-SHURE
K790138 · Nuclear Medical Laboratories, Inc. · Mar 1979
RIA QUANT B-HCG TEST KIT
K781578 · Mallinckrodt Critical Care · Oct 1978
QUANTROLS HCG
K772086 · Organon, Inc. · Nov 1977