Cleared Traditional

K944785 - SAS QUANT HCG SERUM

K944785 is an FDA 510(k) clearance for SAS QUANT HCG SERUM, manufactured by Sa Scientific, Inc.. The device is a Class 1 Chemistry device with product code JJX cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K944785 · Sa Scientific, Inc. · Chemistry device
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Jan 1995
Decision
111d
Days
Class 1
Risk

K944785 is an FDA 510(k) clearance for the SAS QUANT HCG SERUM. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Sa Scientific, Inc. (San Antonio, US). The FDA issued a Cleared decision on January 17, 1995 after a review of 111 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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 Sa Scientific, Inc. devices

FDA 510(k) Submission Details - K944785

510(k) Number K944785 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1994
Decision Date January 17, 1995
Days to Decision 111 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
23d slower than avg
Panel avg: 88d · This submission: 111d
Pathway characteristics
Predicate-based equivalence.

JJX Device Classification - Class 1, General Controls

Product Code JJX Single (specified) Analyte Controls (assayed And Unassayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JJX Single (specified) Analyte Controls (assayed And Unassayed)

All 436
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