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SAS Serum/Urine hCG Modification

FDA 510(k)

Class II (US FDA 510(k))

510(k) K990684

by Sa Scientific, Inc.

Identifiers

510(k) Number
K990684 FDA 510(k)
FDA Product Code
JHI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.1155 FDA 510(k)
Regulation Number
862.1155 FDA 510(k)
Advisory Committee
Clinical Chemistry FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a visual, qualitative pregnancy test for detecting human chorionic gonadotropin (hCG) in serum or urine samples. It is classified as a Clinical Chemistry device and functions as an in vitro diagnostic tool to aid in early pregnancy detection by identifying the presence of hCG, a hormone produced during pregnancy.

The SAS Serum/Urine hCG Modification is intended for use in clinical laboratory settings by trained healthcare professionals. It is a single-use, prescription-use device with no indication of sterility or MRI safety requirements. The device is authorized under FDA 510(k) clearance (K990684) and falls under Class II regulatory classification (21 CFR 862.1155). No third-party review or PCCP authorization is noted.

Frequently asked questions

What is the SAS Serum/Urine hCG Modification used for?

The SAS Serum/Urine hCG Modification is a visual, qualitative pregnancy test designed to detect human chorionic gonadotropin (hCG) in serum or urine samples. It aids in early pregnancy detection by identifying the presence of hCG, a hormone produced during pregnancy. This device is intended exclusively for use in clinical laboratory settings by trained healthcare professionals.

How is the SAS Serum/Urine hCG Modification supplied and what are its usage instructions?

The device is supplied as a single-use, prescription-only product. It is classified as a Clinical Chemistry in vitro diagnostic tool. Usage involves applying a serum or urine sample to the test, following the manufacturer’s instructions for visual interpretation of results. Detailed instructions are included with each unit, and it must be used in a clinical lab setting by trained personnel.

Is the SAS Serum/Urine hCG Modification sterile?

The provided device data does not explicitly state whether the SAS Serum/Urine hCG Modification is sterile. However, as it is intended for clinical laboratory use and designed for single-use, it is typically handled in a controlled environment to minimize contamination risks. For precise sterility information, refer to the manufacturer’s instructions or packaging.

What regulatory approval does the SAS Serum/Urine hCG Modification hold?

The SAS Serum/Urine hCG Modification is authorized under FDA 510(k) clearance with the clearance number K990684. It is classified under 21 CFR 862.1155 and falls under Class II regulatory classification. This clearance indicates that the device is deemed substantially equivalent to a predicate device already on the market.

Are there different models or sizes available for the SAS Serum/Urine hCG Modification?

The device data lists multiple FEI numbers, which may correspond to different lot or batch identifiers rather than distinct models or sizes. The SAS Serum/Urine hCG Modification is primarily described as a singular product line with no explicit mention of varying models or sizes. For detailed specifications, consult the manufacturer’s documentation or contact Sa Scientific, Inc.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: MODIFICATION OF SAS SERUM/URINE HCG (K990684) - FDA 510 (k), MODIFICATION OF SAS SERUM/URINE HCG 510(k) K990684 - FDA.report, MODIFICATION OF SAS SERUM/URINE HCG (K990684) — FDA 510 (k) | Innolitics, MODIFICATION OF SAS SERUM/URINE HCG (K990684) - Innolitics, PDF K990684 - Modification of Sas Serum/Urine Hcg

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Sa Scientific, Inc.

Sources (1)

  • FDA 510(k) K990684 24 fields · synced Oct 1, 2026