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Sas Blood/Serum/Urine/Urine Hcg

FDA 510(k)

Class II (US FDA 510(k))

510(k) K022683

by Sa Scientific, Inc.

Identifiers

510(k) Number
K022683 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, Pregnancy HCG, Prescription Use diagnostic test, classified as a Class II medical device. It is designed for the qualitative detection of human chorionic gonadotropin (HCG) in blood, serum, and urine samples, aiding in the confirmation of pregnancy. The test provides a visual readout to determine the presence or absence of HCG, a hormone produced during pregnancy.

The SAS Visual Pregnancy HCG Test is supplied as a single-use, non-sterile diagnostic device intended for use in clinical chemistry settings. It is regulated under the FDA’s 510K clearance and falls under the Clinical Chemistry advisory committee. The device requires no special storage conditions beyond those specified in the accompanying instructions and is intended for prescription use only. No MRI safety information is provided, and its regulatory status is confirmed as Substantially Equivalent to a predicate device.

Frequently asked questions

What types of samples can the SAS BLOOD/SERUM/URINE/URINE HCG test detect human chorionic gonadotropin (HCG) in, and how is the result determined?

The SAS BLOOD/SERUM/URINE/URINE HCG test is designed to qualitatively detect HCG in blood, serum, and urine samples. It provides a visual readout—meaning you compare the test line to a control line—to determine whether HCG is present (indicating pregnancy) or absent. The test is classified as a prescription-use diagnostic device, so it requires a healthcare provider’s order for use.

Is the SAS BLOOD/SERUM/URINE/URINE HCG test sterile, and how should it be stored?

The SAS BLOOD/SERUM/URINE/URINE HCG test is non-sterile and intended for single-use only. Storage instructions are provided in the accompanying documentation, but no special conditions (like refrigeration) are required beyond what’s specified there. Always follow the manufacturer’s guidelines to maintain test integrity.

Does this device come in multiple sizes or models, and if so, how would I identify them?

The device is supplied under multiple FEI numbers (e.g., 3013332582, 3003102569, etc.), which correspond to different product codes (JHI) and regulatory filings. These variations likely represent different lot or batch identifiers rather than distinct physical sizes or models. The core functionality remains the same across all versions—qualitative HCG detection in blood, serum, or urine—so compatibility depends on the manufacturer’s instructions for your specific lot.

Can this test be reused, or is it designed for one-time use only?

The SAS BLOOD/SERUM/URINE/URINE HCG test is explicitly labeled as a single-use device. Reusing it could compromise accuracy and introduce contamination risks, as it is not sterile and not intended for repeated testing. Always use a new test for each sample to ensure reliable results.

What regulatory pathway was followed for this device, and how does that affect its use in clinical settings?

The SAS BLOOD/SERUM/URINE/URINE HCG test received FDA 510(k) clearance under the Traditional pathway, with a decision of Substantially Equivalent (SESE) to a predicate device. It falls under the Clinical Chemistry advisory committee and is classified as a Class II medical device. This means it has undergone FDA review for safety and performance but does not require additional prescriptive controls beyond standard clinical chemistry protocols. Its use is restricted to prescription-only settings, as specified.

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.

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) K022683 24 fields · synced Sep 19, 2026