Cleared Traditional

K832879 - B-SLIDE PREGNATE PREGNANCY TEST KIT

K832879 is the FDA 510(k) clearance for B-SLIDE PREGNATE PREGNANCY TEST KIT by Fisher Scientific Co., LLC. It is a Class 2 Chemistry device (product code JHJ) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K832879 · Fisher Scientific Co., LLC · Chemistry device
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Oct 1983
Decision
63d
Days
Class 2
Risk

K832879 is an FDA 510(k) clearance for the B-SLIDE PREGNATE PREGNANCY TEST KIT. Classified as Agglutination Method, Human Chorionic Gonadotropin (product code JHJ), Class II - Special Controls.

Submitted by Fisher Scientific Co., LLC (Mchenry, US). The FDA issued a Cleared decision on October 28, 1983 after a review of 63 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 Fisher Scientific Co., LLC devices

Submission Details

510(k) Number K832879 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1983
Decision Date October 28, 1983
Days to Decision 63 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
25d faster than avg
Panel avg: 88d · This submission: 63d
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 41
Devices cleared under the same product code (JHJ) and FDA review panel - the closest regulatory comparables to K832879.
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
QUICK-TELL INDIRECT PREGNANCY TEST
K832640 · Stanbio Laboratory · Oct 1983
EARLY IN HOME PREGNANCY TEST
K832599 · Warner-Lambert Co. · Sep 1983
FERTITELL DIRECT PREGNANCY TEST #1100
K832557 · Stanbio Laboratory · Sep 1983