Alert a, Hdl-Apoliporotein a, Test Kit

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K802610 ↗

FDA Product Code

DER

Device Class

Class II

Regulation

21 CFR Part 866.5580

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Low Ionic Strength Solution (Liss)

  Class II

  FDA 510(k) K791113 Active Cleared 28 Jun 1979

• Las-R Human Plasminogen Test

  Class I

  FDA 510(k) K772085 Active Cleared 24 Jan 1978

• Q-Pak Chemistry Radioreceptor Control C

  Class II

  FDA 510(k) K770012 Active Cleared 18 Apr 1977

• Tma Bicarbonate/Glycerol Diluent

  Not classified

  FDA 510(k) K771700 Active Cleared 11 Nov 1977

• Las-R Human Ige Test

  Class II

  FDA 510(k) K780753 Active Cleared 6 Jun 1978

• Las-R Test Program

  Class II

  FDA 510(k) K771226 Active Cleared 21 Jul 1977

See all devices from Hyland Therapeutic Div., Travenol Laboratories →

• What clinical purpose does the Alert A HDL-Apolipoprotein A Test Kit serve in patient assessment?

  The Alert A HDL-Apolipoprotein A Test Kit is used to qualitatively detect HDL-apolipoprotein A in human serum or plasma. This helps laboratories assess high-density lipoprotein (HDL) metabolism, which is relevant for evaluating a patient’s cardiovascular risk. It supports diagnostic workflows in immunology-based testing environments.

• Is this test kit designed for single-use or repeated testing, and how should it be stored?

  The Alert A HDL-Apolipoprotein A Test Kit is explicitly designed for single-use only as a diagnostic reagent. It requires standard refrigeration for storage—no additional conditions are specified—so it remains stable until use. Always check the expiration date before use.

• What regulatory pathway was followed for FDA clearance of this device, and what class does it belong to?

  The Alert A HDL-Apolipoprotein A Test Kit was cleared through the traditional 510(k) pathway under FDA’s Class II designation (K802610). It was reviewed by the Immunology (IM) Advisory Committee and determined to be substantially equivalent to a predicate device, adhering to FDA’s immunology-based diagnostic standards.

• Can this test kit be used outside a laboratory setting, or is it strictly for professional use?

  The Alert A HDL-Apolipoprotein A Test Kit is intended for laboratory use only. It is not designed for point-of-care or home testing, as it requires controlled diagnostic environments and specialized handling of reagents and controls.