(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 < -10 degrees Celsius and desiccated. | Stored at < -10 degrees Celsius and desiccated, the controls are stable for a minimum of 2 years from the manufacture date. |
| Material Safety: Human serum and red blood cells used for preparation are certified negative for infectious disease agents. | 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. |
2. Sample size used for the test set and the data provenance
The document specifies that "Each manufactured lot of blood spot controls is analyzed" to verify performance. However, it does not provide a specific numerical sample size for the test set or the number of controls per lot that are tested.
Data Provenance: The device performance verification is conducted at Astoria-Pacific's laboratory on dedicated SPOTCHECK systems. The data is prospective, as each newly manufactured lot is tested. The country of origin for the data is implied to be the United States (Oregon), where Astoria-Pacific, Inc. is located.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not specify the use of external experts to establish the ground truth for the test set for the performance verification of these controls. The verification is performed internally by Astoria-Pacific's laboratory personnel, who are implicitly considered qualified to conduct these tests using FDA-cleared reagent kits and dedicated systems.
4. Adjudication method for the test set
The document does not describe an adjudication method involving multiple readers or experts for the test set's ground truth. The performance verification appears to be based on direct measurement of enzyme activity against established assay cutoffs, as assessed internally by Astoria-Pacific's laboratory.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. The SPOTCHECK® Blood Spot Controls are quality control materials, not an AI-powered diagnostic device. Therefore, no MRMC comparative effectiveness study involving human readers or AI assistance was conducted or reported in this 510(k) summary.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The SPOTCHECK® Blood Spot Controls are not an algorithm or an AI system. They are physical quality control materials used in laboratory assays. The "standalone performance" in this context refers to the intrinsic performance of the control materials themselves, which is verified by enzyme activity measurements as described in Section 1.
7. The type of ground truth used
The ground truth used for verifying the SPOTCHECK® Blood Spot Controls is based on direct measurement of enzyme activity using FDA-cleared SPOTCHECK Biotinidase and Uridyl Transferase 50-Hour Reagent Kits. The "normal" and "deficient" classifications are determined by whether the measured enzyme activity falls above or below established assay cutoff values, respectively. This is a form of empirical measurement against a predefined standard.
8. The sample size for the training set
This is not applicable. The SPOTCHECK® Blood Spot Controls are quality control materials, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI or algorithm development. The phrase "training set" is usually associated with supervised learning scenarios where an algorithm learns from labeled data.
9. How the ground truth for the training set was established
This is not applicable for the same reasons as outlined in Section 8. As there is no training set for an algorithm, there is no ground truth established for such a set.
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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 < - 10 degrees Celsius and desiccated. Stored in this manner, the controls are stable for a minimum of 2 years from the manufacture date.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Astoria-Pacific, Inc. c/o Mr. Charles A. Peterson, CEO 15130 SE 82nd Dr. Clackamas, OR 97015
DEC 1 4 2009
Re: K090940
Trade/Device Name: Astoria-Pacific SPOTCHECK® Blood Spot Controls Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I, reserved Product Code: JJT Dated: October 19, 2009 Received: October 21, 2009
Dear Mr. Peterson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (feporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
CA
Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indication For Use .
510(k) K090940 ·
Device Name: Astoria-Pacific SPOTCHECK® Blood Spot Controls
Indication 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.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)
Carol Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K090940
§ 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.