Cleared Traditional

K831125 - BTC URINE LCG ASSAY

K831125 is an FDA 510(k) clearance for BTC URINE LCG ASSAY, manufactured by Btc Diagnostics, Inc.. The device is a Class 2 Immunology device with product code JHJ cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K831125 · Btc Diagnostics, Inc. · Immunology device
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May 1983
Decision
30d
Days
Class 2
Risk

K831125 is an FDA 510(k) clearance for the BTC URINE LCG ASSAY. Classified as Agglutination Method, Human Chorionic Gonadotropin (product code JHJ), Class II - Special Controls.

Submitted by Btc Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 5, 1983 after a review of 30 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 Btc Diagnostics, Inc. devices

FDA 510(k) Submission Details - K831125

510(k) Number K831125 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1983
Decision Date May 05, 1983
Days to Decision 30 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 105d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JHJ Device Classification - Class 2, Special Controls

Product Code JHJ Agglutination Method, Human Chorionic Gonadotropin
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 - JHJ Agglutination Method, Human Chorionic Gonadotropin

All 55
Devices cleared under the same product code (JHJ) and FDA review panel - the closest regulatory comparables to K831125.
HCG-CHECK
K831466 · Diagnostic Technology, Inc. · Jun 1983
B HCG-CHECK
K831468 · Diagnostic Technology, Inc. · Jun 1983
NEO-PREGNOSTICON DUOCLON TUBE TEST
K831339 · Organon, Inc. · Jun 1983
BETA FFIRM TEST
K823682 · Organon, Inc. · Jan 1983
PREG/TEX PREGNANCY TEST
K821387 · Texas Immunology, Inc. · Jun 1982
ACCURATE BETA
K812967 · Organon, Inc. · Nov 1981