Identifiers
- 510(k) Number
- K974512 FDA 510(k)
- FDA Product Code
- DHA 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 AimStick PBD Combo Pregnancy is a System, Test, Human Chorionic Gonadotropin designed for qualitative detection of human chorionic gonadotropin (hCG) in urine or serum. It employs a lateral flow immunoassay utilizing monoclonal and polyclonal antibodies to identify hCG concentrations at or above 20 mIU/mL, enabling early pregnancy confirmation.
This device is intended for single-use in clinical chemistry settings and requires no special sterility beyond standard handling. It is not MRI-safe and must be stored according to manufacturer instructions. The device holds FDA 510(k) clearance (K974512) under regulatory classification DHA (Diagnostic, Human, Analyte) and is governed by 21 CFR 862.1155. No third-party review or additional authorizations are indicated.
Frequently asked questions
What is the AimStick PBD Combo Pregnancy Test System used for?
The AimStick PBD Combo Pregnancy Test System is designed for the qualitative detection of human chorionic gonadotropin (hCG) in urine or serum samples. It uses a lateral flow immunoassay with monoclonal and polyclonal antibodies to identify hCG concentrations at or above 20 mIU/mL, enabling early confirmation of pregnancy in clinical settings.
How is the AimStick PBD Combo Pregnancy Test System supplied and intended for use?
This device is intended for single-use in clinical chemistry settings. It does not require special sterility beyond standard handling procedures. The test is administered by applying urine or serum to the device, following the manufacturer’s instructions for accurate results.
Is the AimStick PBD Combo Pregnancy Test System sterile?
The device does not require special sterility beyond standard handling practices. Since it is intended for single-use in clinical settings, proper aseptic techniques should be followed during use to ensure reliability and safety.
Can the AimStick PBD Combo Pregnancy Test System be reused?
No, the AimStick PBD Combo Pregnancy Test System is explicitly designed for single-use only. Reusing the device could compromise accuracy and introduce contamination risks, which is why it is not recommended.
What storage instructions apply to the AimStick PBD Combo Pregnancy Test System?
The device must be stored according to the manufacturer’s instructions, which likely include protection from extreme temperatures, moisture, and direct sunlight. Improper storage could affect its performance and validity.
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: AIMSTICK PBD COMBO PREGNANCY (K974512) — FDA 510(k) | Innolitics, K974512 FDA 510 (k) - AIMSTICK PBD COMBO PREGNANCY, Germaine Laboratories AimStick PBD Combo Pregnancy (8288)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K974512 | Class II | Active |
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Manufacturer
- Manufacturer
- Germaine Laboratories, Inc.
Sources (1)
- FDA 510(k) K974512 24 fields · synced Oct 1, 2026