Cleared Abbreviated

K020438 - SAS VALUE HCG

K020438 is the FDA 510(k) clearance for SAS VALUE HCG by Sa Scientific, Inc.. It is a Class 2 Chemistry device (product code JHI) cleared through the Abbreviated 510(k) pathway after a 25-day FDA review.

K020438 · Sa Scientific, Inc. · Chemistry device
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Mar 2002
Decision
25d
Days
Class 2
Risk

K020438 is an FDA 510(k) clearance for the SAS VALUE 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 March 8, 2002 after a review of 25 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Sa Scientific, Inc. devices

Submission Details

510(k) Number K020438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2002
Decision Date March 08, 2002
Days to Decision 25 days
Submission Type Abbreviated
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
63d faster than avg
Panel avg: 88d · This submission: 25d
Pathway characteristics
Standards-based clearance path.

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 K020438.
STATUS HCG SERUM/URINE
K020439 · Princeton BioMeditech Corp. · May 2002
QUICKVUE ONE-STEP HCG-URINE
K020799 · Quidel Corp. · May 2002
QUICKVUE ONE-STEP HCG-COMBO
K020801 · Quidel Corp. · May 2002
ACTIVE FREE BETA-HCG ELISA, MODEL DSL-10-8500
K020128 · Diagnostic Systems Laboratories, Inc. · Mar 2002
SUREVUE URINE HCG
K010522 · Sa Scientific, Inc. · Jul 2001
SUREVUE SERUM/URINE HCG, MODEL 1,30,50,100 TEST KIT
K010593 · Sa Scientific, Inc. · Apr 2001