(255 days)
No
The device description and performance studies focus on the preparation and testing of blood spot controls with known enzyme activity levels for quality control purposes in laboratory assays. There is no mention of AI or ML being used for analysis, interpretation, or any other function of the device.
No
The device is described as "Blood Spot Controls" used for monitoring assay performance in in vitro diagnostic newborn screening. It does not treat or prevent any condition.
No
The device is described as "Blood Spot Controls" used for "monitoring assay performance" of diagnostic tests, not for direct diagnosis of a patient's condition.
No
The device is a physical blood spot control, not a software application. It is a biological material spotted on filter paper used to monitor the performance of in vitro diagnostic assays.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the controls are used for "monitoring assay performance during in vitro diagnostic newborn screening." This directly aligns with the definition of an IVD, which are reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae.
- Device Description: The description details the composition and preparation of the controls, which are used in a laboratory setting to assess the performance of diagnostic assays.
- Performance Studies: The summary of performance studies describes how the controls are tested to verify their suitability for monitoring the performance of FDA-cleared diagnostic kits.
- Predicate Device: The mention of a predicate device (K990827; Bio-Rad Laboratories Quantase Neonatal GALT control set) which is also an IVD control, further supports the classification of this device as an IVD.
The device is designed to be used in vitro (outside the body) to evaluate the performance of diagnostic tests, which is a core function of an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes
JJT
Device Description
SPOTCHECK Blood Spot Controls are used for monitoring assay performance during in vitro diagnostic newborn screening for deficient Galactose-1-phosphate Uridyltransferase (GALT) and Biotinidase enzyme activity. The controls are prepared with mixtures of human serum and human red blood cells, adjusted to approximately 55% hematocrit, and spotted on Whatman 903A filter paper. Enzyme activity in the Deficient Control is decreased by heating, while the Normal Control's enzyme activity is supported by the addition of dithioerythritol (DTE). The controls provide an ongoing indication of assay performance, with the Deficient Control responding below the assay cutoff and the Normal Control responding above the assay cutoff within normal limits.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
newborn
Intended User / Care Setting
trained, qualified laboratory personnel
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Each manufactured lot of blood spot controls is analyzed to verify that either the Normal Control contains sufficient enzyme activity to be labeled as normal or conversely, that the Deficient Control has clinically deficient enzyme activity. Control lots are individually tested using FDA-cleared SPOTCHECK Biotinidase and Uridyl Transferase 50-Hour Reagent Kits to determine the response of each analyte (enzyme) present. The controls are analyzed in Astoria-Pacific's laboratory on dedicated SPOTCHECK systems maintained for quality control purposes. Results are included in the product insert.
Key Metrics
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Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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INTERNATIONAL
510(k) Summary, K090940
1. Name, Address of Contact Person Applicants name and address Astoria-Pacific, Inc. FDA Establishment No. 3050015 15130 SE 82nd Drive Post Office Box 830 Clackamas, OR 97015-0830 Tel 1-503-657-3010 Fax 1-503-655-7367 Charles A. Peterson CEO Jason Reynolds Official Correspondent
2. Name of the Device
Product Classification
Regulation Number: 21 CFR 862.1660
510(k) Number: K090940
Classification Panel: Clinical Chemistry
Product Code: JJT
Device Classification: Class I
Product Nomenclature
Common Name: Blood Spot Controls
Classification Name: Quality control material (assayed and unassayed)
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510(k) Summary, K090940
Proprietary Name: SPOTCHECK® Blood Spot Control
Model Number: Part No. 80-0900P4K, Deficient; Part No. 80-0901P4K, Normal
3. Identification of the legally-marketed device for which substantial equivalence is claimed
The proposed device is substantially equivalent to Bio-Rad Laboratories Quantase Neonatal GALT control set, item 532-6002, intended for use with the MICROPLATE NEONATAL GALT ASSAY kit, item 532-6001 (classification name "fluorescent proc. (qual.), galactose-1-phosphate uridyl transferase"), K990827.
4. Description of the Device
SPOTCHECK Blood Spot Controls
CONTENTS:
Part No. 80-0900P4K, Blood Spot Controls, Deficient; 4 cards
Part No. 80-0901P4K, Blood Spot Controls, Normal; 4 cards
Commercial assays screening for enzyme activity are used to detect inborn errors of metabolism involving Galactose-1-Phosphate Uridyltransferase (GALT) and Biotinidase enzyme deficiencies. The presence of sufficient enzyme activity indicates a negative result for the assay. The lack of enzyme activity, or greatly reduced enzyme activity, indicates a presumptive positive result for the metabolic error and requires follow up and testing.
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. Individual laboratories must establish their own values and limits of variance based upon the appropriate assay's performance.
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5. Statement of Intended Use
SPOTCHECK Blood Spot Controls are used for monitoring assay performance during in vitro diagnostic newborn screening for deficient Galactose-1-phosphate Uridyltransferase (GALT) and/or Biotinidase enzyme activity. Enzyme response quantitation is provided in the product insert.
The controls are treated in the same manner as patient samples in the course of analysis, and are intended for use by trained, qualified laboratory personnel.
6. Blood Spot Controls Activity Verification
Each manufactured lot of blood spot controls is analyzed to verify that either the Normal Control contains sufficient enzyme activity to be labeled as normal or conversely, that the Deficient Control has clinically deficient enzyme activity. Control lots are individually tested using FDA-cleared SPOTCHECK Biotinidase and Uridyl Transferase 50-Hour Reagent Kits to determine the response of each analyte (enzyme) present. The controls are analyzed in Astoria-Pacific's laboratory on dedicated SPOTCHECK systems maintained for quality control purposes. Results are included in the product insert.
7. Stability
Recommended storage conditions for the Blood Spot Controls are