Cleared Traditional

K010522 - SUREVUE URINE HCG

K010522 is an FDA 510(k) clearance for SUREVUE URINE HCG, manufactured by Sa Scientific, Inc.. The device is a Class 2 Toxicology device with product code JHI cleared through the Traditional 510(k) pathway after a 159-day FDA review.

K010522 · Sa Scientific, Inc. · Toxicology device
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Jul 2001
Decision
159d
Days
Class 2
Risk

K010522 is an FDA 510(k) clearance for the SUREVUE URINE HCG. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Sa Scientific, Inc. (San Antonio, US). The FDA issued a Cleared decision on July 31, 2001 after a review of 159 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1155 - the FDA toxicology device 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 Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K010522

510(k) Number K010522 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2001
Decision Date July 31, 2001
Days to Decision 159 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d slower than avg
Panel avg: 87d · This submission: 159d
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 Toxicology devices follow this clearance model.

Regulatory Peers - JHI Visual, Pregnancy Hcg, Prescription Use

All 358
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K010522.
UNIMARK HCG COMBO PREGNANCY TEST
K013194 · Biotech Atlantic, Inc. · Oct 2001
WH ACCU TEST PREGNANCY TEST
K012284 · W.H.P.M., Inc. · Aug 2001
HCG STAT PAK ULTRA-FAST
K011550 · Chembio Diagnostic Systems, Inc. · Aug 2001
SUREVUE SERUM/URINE HCG, MODEL 1,30,50,100 TEST KIT
K010593 · Sa Scientific, Inc. · Apr 2001
EZ-HCG URINE(PREGNANCY TEST)
K003856 · Biomerica, Inc. · Feb 2001
DBEST HCG 2 IU/ML TEST KIT
K001215 · Ameritek, Inc. · Jun 2000
K010522 · SUREVUE URINE HCG
Download PDF Sa Scientific, Inc.