Acon Combo Pregnancy

• • Ongoing Z-3272-2026 FDA Class II ·initiated 20 Aug 2026

  hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.

510(k) Number

K993065 ↗

FDA product code

JHI

Device class

Class II

Regulation

21 CFR Part 862.1155

Advisory committee

Clinical Chemistry

FDA decision

SESE Substantially Equivalent

• Mission® Cholesterol Test Device 3-in-1 Lipid Panel

  Class C

  CE/IVDR V76 104507 0014 Active Valid to Aug 2031

• Mission® Cholesterol Meter

  Class C

  CE/IVDR V76 104507 0014 Active Valid to Aug 2031

• Mission® Cholesterol Optical Check Device

  Class C

  CE/IVDR V76 104507 0014 Active Valid to Aug 2031

• Mission® Cholesterol Monitoring System

  Class C

  CE/IVDR V76 104507 0014 Active Valid to Aug 2031

• Mission U120 Smart Urine Analyzer U117-101

  Class II

  GUDID on market

• Mission U120 Smart Urine Analyzer U117-111

  Class I

  GUDID on market

See all devices from Acon Laboratories, Inc. →

• What types of samples can the Acon Combo Pregnancy device detect human chorionic gonadotropin (hCG) in, and how is it used?

  The Acon Combo Pregnancy device is designed to detect hCG in both urine and serum samples, making it versatile for clinical chemistry settings like hospitals, labs, and physician offices. It uses a lateral flow membrane immunoassay with monoclonal and polyclonal antibodies to identify hCG. No additional processing is required beyond applying the sample—it comes as a ready-to-use cassette, simplifying workflow for users.

• Is the Acon Combo Pregnancy device intended for single-use or repeated use, and what does this mean for clinical workflows?

  The device is explicitly intended for single-use only, as stated in its regulatory data. This means each cassette is designed for one test, ensuring accuracy and hygiene in clinical settings. Clinicians should discard the device after use to avoid contamination or cross-sample interference, aligning with standard practices for in vitro diagnostics.

• Are there different sizes or models of the Acon Combo Pregnancy device, and how would I identify the correct one for my needs?

  The provided data does not specify distinct sizes or models beyond the core product name (*Acon Combo Pregnancy*). However, the multiple FEI numbers (e.g., 3013332582, 3006198300) suggest variations may exist under different lot or distribution codes. To confirm compatibility, verify the product code (JHI) and registration number with the manufacturer or distributor, as these often correlate to specific versions or packaging.

• How should the Acon Combo Pregnancy device be stored, and are there any special handling requirements?

  While the data does not explicitly detail storage conditions, lateral flow immunoassay devices like this typically require protection from extreme temperatures, moisture, and direct sunlight. The manufacturer’s instructions (not provided here) would outline ideal storage (e.g., room temperature, sealed packaging) to preserve sensitivity. Always check the packaging label for expiration dates and storage symbols (e.g., refrigeration icons) before use.

• What regulatory pathway was followed for the Acon Combo Pregnancy device, and how does this affect its use in clinical settings?

  The device received FDA 510(k) clearance under the *Clinical Chemistry* advisory committee, classified as Class II. This means it was deemed *substantially equivalent* to a predicate device through a traditional review process. Clinicians can rely on its FDA-authorized design and performance claims, though local regulations (e.g., lab accreditation) may still apply. The clearance does not imply MRI safety or sterility requirements, so standard infection control protocols should be followed.