(255 days)
SPOTCHECK Blood Spot Controls are used for monitoring assay performance during in vitro diagnostic newborn screening for deficient Galactose-1-phosphate UridyItransferase (GALT) and/or Biotinidase enzyme activity. Enzyme response quantitation is provided in the product insert.
SPOTCHECK Blood Spot Controls. Part No. 80-0900P4K, Blood Spot Controls, Deficient; 4 cards. Part No. 80-0901P4K, Blood Spot Controls, Normal; 4 cards. The controls are prepared with mixtures of human serum and human red blood cells. adjusted to approximately 55% hematocrit. Enzyme activity in the Deficient Control is decreased by heating. Enzyme activity in the Normal Control is supported by the addition of dithioerythritol (DTE). The mixtures are spotted on Whatman 903A filter paper and allowed to air dry at room temperature. The suppliers of serum and red blood cells certify that the materials have been tested using FDA-approved assays and shown to be negative for infectious disease agents. The SPOTCHECK Blood Spot Controls provide an ongoing indication of the assay performance. The Deficient Control responds below the assay cutoff, and the Normal Control responds above the assay cutoff within normal limits.
The provided 510(k) summary (K090940) describes a medical device, the SPOTCHECK® Blood Spot Controls, which are quality control materials for newborn screening assays. The acceptance criteria and the study proving the device meets these criteria are detailed below.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Normal Control: Contains sufficient enzyme activity to be labeled as "normal." | Each manufactured lot of Normal Control is tested using FDA-cleared SPOTCHECK Biotinidase and Uridyl Transferase 50-Hour Reagent Kits. The Normal Control responds above the assay cutoff, within normal limits, as verified in Astoria-Pacific's laboratory. |
| Deficient Control: Has clinically deficient enzyme activity. | Each manufactured lot of Deficient Control is tested using FDA-cleared SPOTCHECK Biotinidase and Uridyl Transferase 50-Hour Reagent Kits. The Deficient Control responds below the assay cutoff, as verified in Astoria-Pacific's laboratory. |
| Stability: Stable for a minimum of 2 years from the manufacture date when stored at |
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.