Cleared Traditional

K874258 - VENTRESCREEN, HCG URINE

K874258 is an FDA 510(k) clearance for VENTRESCREEN, manufactured by Ventrex Laboratories, Inc.. The device is a Class 2 Chemistry device with product code JHI cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K874258 · Ventrex Laboratories, Inc. · Chemistry device
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Nov 1987
Decision
34d
Days
Class 2
Risk

K874258 is an FDA 510(k) clearance for the VENTRESCREEN, HCG URINE. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Ventrex Laboratories, Inc. (Portland, US). The FDA issued a Cleared decision on November 23, 1987 after a review of 34 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 Ventrex Laboratories, Inc. devices

FDA 510(k) Submission Details - K874258

510(k) Number K874258 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1987
Decision Date November 23, 1987
Days to Decision 34 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
54d faster than avg
Panel avg: 88d · This submission: 34d
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 288
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K874258.
KODAK SURECELL(TM) HCG-URINE KIT
K874388 · Eastman Kodak Company · Feb 1988
IRMA-COUNT HCG W/MONO. ANTIBODIES RKCG1,5,X
K874033 · Diagnostic Products Corp. · Jan 1988
CARDS(TM) HCG-SERUM/URINE CR-7503 AND CR-7504
K873788 · Pacific Biotech, Inc. · Nov 1987
RESULT PLUS/HCG PREGNANCY TEST
K872730 · Ortho Diagnostic Systems, Inc. · Oct 1987
AFFINITY HCG IMMUNIT (POLYCLONAL)
K873524 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1987
HCG SEROZYME IMMUNOENZYM ASSAY KIT/MAG SOLID PHASE
K873033 · Serono Diagnostics, Inc. · Sep 1987