Cleared Traditional

K931302 - SAS PREGNANCY STRIP

K931302 is the FDA 510(k) clearance for SAS PREGNANCY STRIP by Sa Scientific, Inc.. It is a Class 2 Chemistry device (product code JHI) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K931302 · Sa Scientific, Inc. · Chemistry device
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Jun 1993
Decision
86d
Days
Class 2
Risk

K931302 is an FDA 510(k) clearance for the SAS PREGNANCY STRIP. 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 June 9, 1993 after a review of 86 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 Sa Scientific, Inc. devices

Submission Details

510(k) Number K931302 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 1993
Decision Date June 09, 1993
Days to Decision 86 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 88d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 163
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K931302.
KODAK SURECELL HCG-SERUM/URINE TEST KIT, MODIFICATION
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QUICKVUE ONE-STEP HCG COMBO
K932042 · Quidel Corp. · Jun 1993
CLEARVIEW HCG
K924673 · Unipath , Ltd. · May 1993
CIBA CORNING ACS HCG IMMUNOASSAY
K925277 · Ciba Corning Diagnostics Corp. · Mar 1993
VISTA(R) HUMAN CHORIONIC GONADOTROPIN (HCG) ASSAY
K926342 · Syva Co. · Feb 1993