Cleared Traditional

K131166 - SOFIA(R) HCG FIA

K131166 is an FDA 510(k) clearance for SOFIA HCG FIA, manufactured by Quidel Corp.. The device is a Class 2 Chemistry device with product code JHI cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K131166 · Quidel Corp. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2013
Decision
100d
Days
Class 2
Risk

K131166 is an FDA 510(k) clearance for the SOFIA(R) HCG FIA. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Quidel Corp. (San Diego, US). The FDA issued a Cleared decision on August 2, 2013 after a review of 100 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K131166

510(k) Number K131166 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2013
Decision Date August 02, 2013
Days to Decision 100 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
12d slower than avg
Panel avg: 88d · This submission: 100d
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 334
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K131166.
Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip
K152768 · Assure Tech. Co., Ltd. · Feb 2016
WUNDER PREGNANCY TEST
K130456 · James Nguyen · Apr 2014
FASTEP S10 HCG SERUM/URINE COMBO TEST
K132834 · Polymed Therapeutics, Inc. · Jan 2014
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
K131166 · SOFIA(R) HCG FIA
Download PDF FDA Summary Quidel Corp.