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
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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.

View all Quidel Corp. devices

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 250
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K131166.
Innovita HCG Pregnancy Rapid Combo Test
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Alltest Pregnancy Rapid Combo Test Cassette
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K172322 · Siemens Healthcare Diagnostics, Inc. · Mar 2018
RAPIDVUE HCG TEST
K102175 · Quidel Corporation · Aug 2010
LIFESIGN DXPRESS, MODEL LSR2000
K050955 · Princeton BioMeditech Corp. · Jan 2006
ACON SPECTRUM URINE/SERUM PREGNANCY TEST DEVICE
K041946 · ACON Laboratories, Inc. · Aug 2004