Cleared Traditional

K062361 - INNOVACON HCG UKTRA TEST DEVICE

K062361 is an FDA 510(k) clearance for INNOVACON HCG UKTRA TEST DEVICE, manufactured by Innovacon, Inc.. The device is a Class 2 Chemistry device with product code JHI cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K062361 · Innovacon, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2006
Decision
70d
Days
Class 2
Risk

K062361 is an FDA 510(k) clearance for the INNOVACON HCG UKTRA TEST DEVICE. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Innovacon, Inc. (San Diego, US). The FDA issued a Cleared decision on October 23, 2006 after a review of 70 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 Innovacon, Inc. devices

FDA 510(k) Submission Details - K062361

510(k) Number K062361 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2006
Decision Date October 23, 2006
Days to Decision 70 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
18d faster than avg
Panel avg: 88d · This submission: 70d
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 293
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K062361.
BIONEXIA HCG PREGNANCY CASSETTE AND DIPSTICK TESTS, MODEL 08-HCG AND 02-HCG
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DBEST HCG PANEL TEST KIT
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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