One-Step Pregnancy Dipstick Test
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K964536 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)
The One-Step Pregnancy Dipstick Test is a visual immunoassay device for the qualitative detection of human chorionic gonadotropin (hCG) in urine. It provides a rapid, qualitative visual result for early pregnancy detection using colloidal gold antibody complexes.
This single-use dipstick is intended for professional use in clinical chemistry settings. It is supplied as a non-sterile, single-use device with no special storage requirements beyond protection from extreme temperatures and moisture. The device is classified as a Class II medical device under FDA regulations, with clearance via a 510(k) submission (K964536) and is regulated under 862.1155. No MRI safety considerations are specified.
One-Step Pregnancy Dipstick Test
Frequently asked questions
What clinical setting is the One-Step Pregnancy Dipstick Test designed for, and who should use it?
The One-Step Pregnancy Dipstick Test is designed for professional use in clinical chemistry settings, such as laboratories or physician offices. It is intended for trained healthcare professionals, like clinicians or lab technicians, to perform rapid, qualitative detection of human chorionic gonadotropin (hCG) in urine samples.
Is the One-Step Pregnancy Dipstick Test sterile, and what storage conditions are required?
The One-Step Pregnancy Dipstick Test is not sterile and is supplied as a single-use device. Storage requires only protection from extreme temperatures and moisture—no additional conditions are specified. Keep it in its original packaging until use.
How is the One-Step Pregnancy Dipstick Test regulated, and what does its classification mean?
The device is classified as a Class II medical device under FDA regulations and was cleared via a 510(k) submission (K964536) in 1997. This classification indicates it poses moderate risk and requires special controls beyond general controls to ensure safety and effectiveness. The submission was reviewed by the FDA’s Clinical Chemistry (CH) Advisory Committee and determined to be *substantially equivalent* to a predicate device.
Are there multiple sizes or models of the One-Step Pregnancy Dipstick Test, or is it a single unified product?
The One-Step Pregnancy Dipstick Test appears as a single product line with multiple FEI numbers listed, which typically represent variations in packaging, batch sizes, or minor manufacturing distinctions rather than distinct clinical models. All versions function identically for detecting hCG in urine, so no size or model selection is required for clinical use.
Can this device be reused, or is it strictly for single-use only?
The One-Step Pregnancy Dipstick Test is explicitly labeled as a single-use device. Reusing it is not recommended or supported by the manufacturer, as it could compromise accuracy and introduce contamination risks. Each dipstick should be discarded after a single test.
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: hCG Urine & Serum Combo Dipstick Test | Teco Diagnostics, hCG Urine Dipstick Test | Teco Diagnostics, DEVICE: Teco Diagnostics One-Step Pregnancy Dipstick Test (10673486014006), TECO DIAGNOSTICS ONE-STEP PREGNANCY DIPSTICK TEST… - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K964536 | Class II | Active |
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Manufacturer
- Manufacturer
- Teco Diagnostics
Sources (1)
- FDA 510(k) K964536 24 fields · synced Sep 20, 2026