Cleared Traditional

K842544 - STANBIO QUICK-TELL MONOCLONAL INDIRECT

K842544 is the FDA 510(k) clearance for STANBIO QUICK-TELL MONOCLONAL INDIRECT by Stanbio Laboratory. It is a Class 2 Chemistry device (product code JHJ) cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K842544 · Stanbio Laboratory · Chemistry device
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Sep 1984
Decision
81d
Days
Class 2
Risk

K842544 is an FDA 510(k) clearance for the STANBIO QUICK-TELL MONOCLONAL INDIRECT. Classified as Agglutination Method, Human Chorionic Gonadotropin (product code JHJ), Class II - Special Controls.

Submitted by Stanbio Laboratory (Mchenry, US). The FDA issued a Cleared decision on September 21, 1984 after a review of 81 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 Stanbio Laboratory devices

Submission Details

510(k) Number K842544 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 1984
Decision Date September 21, 1984
Days to Decision 81 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
7d faster than avg
Panel avg: 88d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Chemistry devices follow this clearance model.

Regulatory Peers - JHJ Agglutination Method, Human Chorionic Gonadotropin

All 28
Devices cleared under the same product code (JHJ) and FDA review panel - the closest regulatory comparables to K842544.
TERUMO SENSIBEAD EIG HCG KIT
K854670 · Terumo Medical Corp. · Feb 1986
PREGNANCY CARD TEST
K852066 · Em Diagnostic Systems, Inc. · Jun 1985
ABBOTT PREGNA-PLUS HUMAN CHORIONIC GONADOTROPIN EN
K844914 · Abbott Laboratories · Feb 1985
FERTITUBE PREGNANCY TEST #1120
K832867 · Stanbio Laboratory · Feb 1984
ORTHO B-HCG SLIDE TEST FOR PREGNANCY
K833137 · Ortho Diagnostic Systems, Inc. · Jan 1984
QUIDEL HCG ENZYME IMMUNOASSAY KIT
K833156 · Quidel Corp. · Nov 1983