Cleared Traditional

K990741 - SAS ONE-STEP PREGNANCY

K990741 is the FDA 510(k) clearance for SAS ONE-STEP PREGNANCY by Sa Scientific, Inc.. It is a Class 2 Chemistry device (product code JHI) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K990741 · Sa Scientific, Inc. · Chemistry device
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May 1999
Decision
63d
Days
Class 2
Risk

K990741 is an FDA 510(k) clearance for the SAS ONE-STEP PREGNANCY. 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 May 10, 1999 after a review of 63 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 K990741 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1999
Decision Date May 10, 1999
Days to Decision 63 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
25d faster than avg
Panel avg: 88d · This submission: 63d
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 K990741.
ACON HCG ONE STEP PREGNANCY TEST DEVICE (URINE)
K993317 · ACON Laboratories, Inc. · Dec 1999
ACON COMBO PREGNANCY
K993065 · ACON Laboratories, Inc. · Oct 1999
MODIFICATION OF SAS SERUM/URINE HCG
K990684 · Sa Scientific, Inc. · May 1999
QUICKCARD HCG COMBO TEST, MODEL #9014
K991095 · Phamatech · Apr 1999
INSTANT-VIEW PREGNANCY URINE TEST
K984076 · Alfa Scientific Designs, Inc. · Feb 1999
INSTANT-VIEW PREGNANCY COMBO TEST
K984077 · Alfa Scientific Designs, Inc. · Feb 1999