Cleared Traditional

K050741 - IND ONE STEP HCG PREGNANCY TEST - CASSETTE FORMAT

K050741 is an FDA 510(k) clearance for IND ONE STEP HCG PREGNANCY TEST - CASSE..., manufactured by Ind Diagnostic, Inc.. The device is a Class 2 Chemistry device with product code JHI cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K050741 · Ind Diagnostic, Inc. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2005
Decision
56d
Days
Class 2
Risk

K050741 is an FDA 510(k) clearance for the IND ONE STEP HCG PREGNANCY TEST - CASSETTE FORMAT. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Ind Diagnostic, Inc. (Delta, B.C., CA). The FDA issued a Cleared decision on May 16, 2005 after a review of 56 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.

FDA 510(k) Submission Details - K050741

510(k) Number K050741 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2005
Decision Date May 16, 2005
Days to Decision 56 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 89d · This submission: 56d
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 374
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K050741.
LIFESIGN DXPRESS, MODEL LSR2000
K050955 · Princeton BioMeditech Corp. · Jan 2006
ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES.
K052694 · Ind Diagnostic, Inc. · Dec 2005
WH ACCU TEST ONE-STEP URINE/SERUM COMBO PREGNANCY TEST
K051841 · W.H.P.M., Inc. · Aug 2005
OSOM HCG COMBO TEST
K043385 · Genzyme Diagnostics · Apr 2005
ACON SPECTRUM URINE/SERUM PREGNANCY TEST DEVICE
K041946 · ACON Laboratories, Inc. · Aug 2004
HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE
K041728 · Immunostics Inc., · Aug 2004
K050741 · IND ONE STEP HCG PREGNANCY TEST - CASSETTE FORMAT
Download PDF FDA Summary Ind Diagnostic, Inc.