Cleared Special

K102175 - RAPIDVUE HCG TEST

K102175 is an FDA 510(k) clearance for RAPIDVUE HCG TEST, manufactured by Quidel Corporation. The device is a Class 2 Chemistry device with product code JHI cleared through the Special 510(k) pathway after a 23-day FDA review.

K102175 · Quidel Corporation · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2010
Decision
23d
Days
Class 2
Risk

K102175 is an FDA 510(k) clearance for the RAPIDVUE HCG TEST. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Quidel Corporation (San Diego, US). The FDA issued a Cleared decision on August 25, 2010 after a review of 23 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K102175

510(k) Number K102175 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2010
Decision Date August 25, 2010
Days to Decision 23 days
Submission Type Special
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
66d faster than avg
Panel avg: 89d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

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 375
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K102175.
CHEMTRUE HCG PREGNANCY URINE DIPSTICK, HCG PREGNANCY URINE CASSETTE TEST, AND HCG COMBO SERUM/URINE CASSETTE TEST
K123844 · Chemtron Biotech, Inc. · May 2013
FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS
K112101 · Polymed Therapeutics, Inc. · Jul 2012
HOME PREGNANCY TEST
K112315 · Newscen Coast Bio-Pharmaceutical Co., Ltd. · Apr 2012
FASTPACK HCG IMMUNOASSAY
K072264 · Qualigen, Inc. · Dec 2007
BIONEXIA HCG PREGNANCY CASSETTE AND DIPSTICK TESTS, MODEL 08-HCG AND 02-HCG
K070921 · Applied Dna Technologies, Inc. · Jun 2007
BIONEXIA HCG PREGNANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS, MODELS 08-HCGC AND 02-HCGC
K071030 · Applied Dna Technologies, Inc. · Jun 2007
K102175 · RAPIDVUE HCG TEST
Download PDF FDA Summary Quidel Corporation