Cleared Traditional

K991741 - BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027

K991741 is an FDA 510(k) clearance for BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, manufactured by Biocheck, Inc.. The device is a Class 2 Chemistry device with product code JHI cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K991741 · Biocheck, Inc. · Chemistry device
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Jul 1999
Decision
62d
Days
Class 2
Risk

K991741 is an FDA 510(k) clearance for the BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Biocheck, Inc. (Northridge, US). The FDA issued a Cleared decision on July 22, 1999 after a review of 62 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 Biocheck, Inc. devices

FDA 510(k) Submission Details - K991741

510(k) Number K991741 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 1999
Decision Date July 22, 1999
Days to Decision 62 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 88d · This submission: 62d
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 274
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K991741.
INSURE PRO TEST
K992695 · Inbios Intl., Inc. · Oct 1999
ACON COMBO PREGNANCY
K993065 · ACON Laboratories, Inc. · Oct 1999
ACCUNATE-ONE STEP, ACCUNATE-ONE STEP CASSETTE
K992397 · Cenogenics Corp. · Aug 1999
MODIFICATION OF SAS SERUM/URINE HCG
K990684 · Sa Scientific, Inc. · May 1999
SAS ONE-STEP PREGNANCY
K990741 · Sa Scientific, Inc. · May 1999
QUICKCARD HCG COMBO TEST, MODEL #9014
K991095 · Phamatech · Apr 1999