Cleared Traditional

K841854 - BHCG RIA

K841854 is an FDA 510(k) clearance for BHCG RIA, manufactured by Syncor Intl. Corp.. The device is a Class 2 Chemistry device with product code JHI cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K841854 · Syncor Intl. Corp. · Chemistry device
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Jun 1984
Decision
50d
Days
Class 2
Risk

K841854 is an FDA 510(k) clearance for the BHCG RIA. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Syncor Intl. Corp. (Mchenry, US). The FDA issued a Cleared decision on June 22, 1984 after a review of 50 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 Syncor Intl. Corp. devices

FDA 510(k) Submission Details - K841854

510(k) Number K841854 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 1984
Decision Date June 22, 1984
Days to Decision 50 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
38d faster than avg
Panel avg: 88d · This submission: 50d
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 Chemistry devices follow this clearance model.

Regulatory Peers - JHI Visual, Pregnancy Hcg, Prescription Use

All 207
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K841854.
TANDEM FAST VISUAL HCG ASSAY KIT -
K842633 · Hybritech, Inc. · Aug 1984
STAR HCG MONOCLONAL ANTIBODY IMMUNO
K842598 · Syncor Intl. Corp. · Jul 1984
CA-1511, IN VITRO RADIOIMMUNOASSAY
K841821 · Travenol Laboratories, S.A. · Jun 1984
OREIA II B-HCG PREGNANCY TEST KIT
K841525 · Organon, Inc. · Jun 1984
VENTREZYME BETA-HCG IMMUNOASSAY HCG
K841081 · Ventrex Laboratories, Inc. · May 1984
COATED TUBE HCG IMMUNOASSAY HCG
K841023 · Ventrex Laboratories, Inc. · May 1984