(171 days)
Mission CliniCheck Controls is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the following analytes Acid Phosphatase (Total), Alanine Aminotransferase (ALT/GPT), Albumin, Alkaline Phosphatase (ALP), Alpha Hydroxybutyrate Dehydrogenase (a-HBDH), Amylase, Apolipoprotein A-1, Aspartate Aminotransferase (AST/GOT), Bilirubin (Direct), Bilirubin (Total), C3 Complement C4 Complement, Calcium, Carbon Dioxide (CO2), Chloride, Cholesterol (Total), HDL- Cholesterol, LDL-Cholesterol, Cholinesterase, Creatine Kinase (CK), Creatinine, Gamma Glutamyltransferase (GGT), Glucose, Immunoglobulin A (IgA), Immunoglobulin G (IgG), Immunoglobulin M (IgM), Iron, Iron Binding Capacity, Total (TIBC), Iron Binding Capacity, Unsaturated (UIBC), Lactate (Lactic acid), Lactate Dehydrogenase (LDH), Lipase, Lithium, Magnesium, Phosphorus, Potassium, Protein-Total, Salicylate, Sodium, T3 Free, T3 Total, T Free, T4 Total, Thyroid Stimulating Hormone (TSH), Transferrin, Triglycerides, Urea, Urea Nitrogen, and Uric Acid on instruments listed in the expected values chart.
Mission CliniCheck Assayed Chemistry Control is a human serum based product containing constituents of purified biochemicals (tissue extracts of human and animal origin) chemicals, preservatives and stabilizers. Two levels of Control are provided in a lyophilized form. Each level is packaged into a glass amber bottle containing 5mL of product. The product is packaged in single level boxes (12 x 5mL) or multiple level boxes (6 x 2 x 5mL) and stored at 2 - 8°C. All human source material was tested and found negative by FDA approved methods for HBsAG, HCV, and HIV-1/2.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The provided text does not explicitly state quantitative acceptance criteria in terms of performance metrics (e.g., accuracy, precision limits) for the Mission CliniCheck Assayed Chemistry Control. Instead, the "performance" described relates to stability and shelf-life, demonstrating that the control material maintains its characteristics over time.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Shelf life stability at 2-8°C | Accelerated (high temperature) stress test results support a 2-year shelf life. |
| Use life stability at -20°C (reconstituted) | Use life stability testing at -20°C supports a 20-day life. |
| Use life stability at 2-8°C (refrigerated, reconstituted) | Use life stability testing under refrigerated (2-8°C) conditions supports a 7-day life. |
| Compatibility with predicate device's listed analytes | The device includes all analytes from the predicate device and adds several new ones (Alpha Hydroxybutyrate Dehydrogenase (α-HBDH), Apolipoprotein A-1, C3 Complement, C4 Complement, Immunoglobulin A (IgA), Immunoglobulin G (IgG), Immunoglobulin M (IgM), Iron Binding Capacity, Total (TIBC), T3 Free, T3 Total, T4 Free, T4 Total, Thyroid Stimulating Hormone (TSH)). This implies that the performance for these shared analytes is expected to be substantially equivalent. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not specify a "test set" in the context of typical AI algorithm validation. The tests conducted were related to stability studies for the control material itself. Therefore, the sample size would refer to the number of control units tested for stability, but this information is not provided.
The provenance of this data is internal to the manufacturer, Diamond Diagnostics, Inc., as they conducted these tests to support their product claims. The studies appear to be prospective in nature, as they involve testing the product over time under various conditions (accelerated, refrigerated, frozen) to determine its stability. No information regarding country of origin for the data is provided beyond the applicant's address in Holliston, MA, USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This question is not applicable to the type of device being described. The Mission CliniCheck Assayed Chemistry Control is a quality control material, not a diagnostic device requiring expert interpretation of results to establish "ground truth." Its "truth" is its certified analyte concentrations.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This device does not involve human interpretation or adjudication in the way an AI diagnostic tool would.
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
Not applicable. This is a quality control material and not an AI-assisted diagnostic device that would involve human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a quality control material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device would be the certified values of the analytes within the control material. These values are established through rigorous analytical testing using reference methods and/or expert laboratories to define the expected concentration ranges for each analyte. The document doesn't detail this process, but it is standard for assayed quality control materials.
8. The sample size for the training set
Not applicable. This device is a quality control material, not a machine learning model, so there is no training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
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5. 510(k) Summary
| 510(k) Number: | K103364 | |
|---|---|---|
| Applicant: | Diamond Diagnostics, Inc.333 Fiske StreetHolliston, MA 01746MAY - 6 2011 | |
| Contact Person: | Liann VooDirector, QA and Scientific DevelopmentPhone: (508) 429-0450 ext. 351Fax: (508) 429-0452 | |
| Date Prepared: | March 18, 2011 | |
| Classification Name: | Assayed Quality Control Material | |
| Trade Name: | Mission CliniCheck Assayed Chemistry Control | |
| Device Classification: | 21 CFR 862.1660 | |
| Device Class: | Class I (Controls) | |
| Classification Panel: | CliniCheck Chemistry | |
| Product Code: | JJY | |
| Intended Use: | Mission CliniCheck Controls is intended for use as an assayed quality control serum tomonitor the precision of laboratory testing procedures for the following analytes AcidPhosphatase (Total), Alanine Aminotransferase (ALT/GPT), Albumin, Alkaline Phosphatase(ALP), Alpha Hydroxybutyrate Dehydrogenase (a-HBDH), Amylase, Apolipoprotein A-1,Aspartate Aminotransferase (AST/GOT), Bilirubin (Direct), Bilirubin (Total), C3 ComplementC4 Complement, Calcium, Carbon Dioxide (CO2), Chloride, Cholesterol (Total), HDL-Cholesterol, LDL-Cholesterol, Cholinesterase, Creatine Kinase (CK), Creatinine, GammaGlutamyltransferase (GGT), Glucose, Immunoglobulin A (IgA), Immunoglobulin G (IgG),Immunoglobulin M (IgM), Iron, Iron Binding Capacity, Total (TIBC), Iron Binding Capacity,Unsaturated (UIBC), Lactate (Lactic acid), Lactate Dehydrogenase (LDH), Lipase, Lithium,Magnesium, Phosphorus, Potassium, Protein-Total, Salicylate, Sodium, T3 Free, T3 Total, TFree, T4 Total, Thyroid Stimulating Hormone (TSH), Transferrin, Triglycerides, Urea, UreaNitrogen, and Uric Acid on instruments listed in the expected values chart. | |
| Device Description: | Mission CliniCheck Assayed Chemistry Control is a human serum based productcontaining constituents of purified biochemicals (tissue extracts of human and animal origin)chemicals, preservatives and stabilizers. Two levels of Control are provided in a lyophilizedform. Each level is packaged into a glass amber bottle containing 5mL of product. Theproduct is packaged in single level boxes (12 x 5mL) or multiple level boxes (6 x 2 x 5mL)and stored at 2 - 8°C.All human source material was tested and found negative by FDA approved methods forHBsAG, HCV, and HIV-1/2. | |
| Similarities | ||
| Characteristics | DEVICE | PREDICATE DEVICE |
| Mission CliniCheck Assayed ChemistryControl, K103364 | Mission CliniCheck Assayed ChemistryControl, K093492 | |
| PN | DD-93001D, DD-93002D | Same |
| Intended Use | For in vitro diagnostic use as an assayedquality control serum to monitor the precisionof laboratory testing procedures for thefollowing analytes Acid Phosphatase (Total),Alanine Aminotransferase (ALT/GPT),Albumin, Alkaline Phosphatase (ALP),Amylase, Aspartate Aminotransferase(AST/GOT), Bilirubin (Direct), Bilirubin(Total), Calcium, Carbon Dioxide (CO2),Chloride, Cholesterol (Total), HDL-Cholesterol, LDL-Cholesterol,Cholinesterase, Creatine Kinase (CK),Creatinine, Gamma Glutamyltransferase(GGT), Glucose, Iron,[Iron Binding Capacity,Unsaturated (UIBC)],Lactate (Lactic acid),Lactate Dehydrogenase (LDH), Lipase,Lithium, Magnesium, Phosphorus,Potassium, Protein-Total, Salicylate, Sodium,Transferrin, Triglycerides, Urea, UreaNitrogen, and Uric Acid on instruments whichare listed in the expected values chart. | Same |
| Matrix | Serum | Same |
| Form | Lyophilized | Same |
| Levels | Two | Same |
| Storage | 2-8°C | Same |
| ReconstitutedStability | 20 days at -20°C | Same |
| Shelf Life | 24 months | Same |
Mission CliniCheck Assayed Control 510(K103364) Al
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Mission CliniCheck Assayed Chemistry Control, Levels 1 and 2 Predicate Device Name:
Predicate 510(k) number(s): K093492
Comparison with Predicate Device:
Differences
| Characteristics | Mission CliniCheck Assayed ChemistryControl | Predicate |
|---|---|---|
| Constituents | Contains values for Alpha HydroxybutyrateDehydrogenase (α-HBDH), Apolipoprotein A-1, C3 Complement, C4 Complement,Immunoglobulin A (IgA), Immunoglobulin G (IgG), Immunoglobulin M (IgM), Iron BindingCapacity, Total (TIBC), T3 Free, T3 Total, T4Free, T4 Total, Thyroid Stimulating Hormone(TSH). | Does not contain values for AlphaHydroxybutyrate Dehydrogenase (α-HBDH),Apolipoprotein A-1, C3 Complement, C4Complement, Immunoglobulin A (IgA),Immunoglobulin G (IgG), Immunoglobulin M(IgM), Iron Binding Capacity, Total (TIBC), T3Free, T3 Total, T4 Free, T4 Total, ThyroidStimulating Hormone (TSH). |
| Packaging | 12 x 5 mL | 10 x 5 mL |
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Substantial Equivalence Table of Product Part Numbers & Trade Names
| Diamond/Mission Product | Diamond/Mission Product |
|---|---|
| DD-93001 Mission CliniCheck Assayed | DD-93001 Mission CliniCheck Assayed |
| Chemistry Control, Level 1 | Chemistry Control, Level 1 |
| DD-93002 Mission CliniCheck Assayed | DD-93002 Mission CliniCheck Assayed |
| Chemistry Control, Level 2 | Chemistry Control, Level 2 |
| DD-93012 Mission CliniCheck Assayed | DD-93012 Mission CliniCheck Assayed |
| Chemistry Control, Dual Level | Chemistry Control, Dual Level |
Assessment of Non-Clinical Performance Data:
Tests were conducted to verify specific performance requirements:
- Accelerated (high temperature) stress test was done and results support a 2 year shelf life. .
- Use life stability testing at -20℃ supports a 20 day life. .
- Use life stability testing under refrigerated (2-8°C) conditions support a 7 day life. .
Assessment of Clinical Performance Data:
NA
Conclusions:
Comparison of technological characteristics, formulation and intended use to predicate device listed in this summary support the claim of substantial equivalence.
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Image /page/3/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around an emblem. The emblem depicts a stylized image of an eagle or bird with outstretched wings, symbolizing national strength and protection.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
MAY 8 2011
Diamond Diagnostics, Inc. c/o Liann Voo, Director, Quality Assurance and Scientific Development 333 Fiske Street Holliston, MA 01746
Re: K103364
Trade Name: Mission CliniCheck Assayed Chemical Control Regulation Number: 21 CFR §862.1660 Regulation Name: Quality Control Material (assayed and unassayed) Regulatory Class: Class I, reserved Product Codes: JJY Dated: March 18, 2011 Received: March 21, 2010
Dear Ms. Voo:
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 either class II (Special Controls) or class III (PMA), 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 (reporting 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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Page 2 -
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), 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 premarks notification" (21 CHR Part 807.97). 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 tolli-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
C.C.
Courtney Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
: ১৮৮ :
Enclosure
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4. Indications for Use Statement
510(k) Number (if known): K103364
· Device Name: Mission CliniCheck Assayed Chemistry Control
Indications For Use:
Mission CliniCheck Controls is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the following analytes, Acid Phosphatase (Total), Alanine Aminotransferase (ALT/GPT), Albumin, Alkaline Phosphatase (ALP), Alpha Hydroxybutyrate Dehydrogenase (a-HBDH), Amylase, Apolipoprotein A-1, Aspartate Aminotransferase (AST/GOT), Bilirubin (Direct), Bilirubin (Total), C3 Complement, C4 Complement, Calcium, Carbon Dioxide (CO2), Chloride, Cholesterol (Total), HDL-Cholesterol, LDL-Cholesterol, Cholinesterase, Creatine Kinase (CK), Creatinine, Gamma Glutamyltransferase (GGT), Glucose, Immunoglobulin G (IgC), Immunoglobulin G (IgG), Immunoglobulin M (IgM), Iron, Iron Binding Capacity, Total (TIBC), Iron Binding Capacity, Unsaturated (UIBC), Lactate (Lactic acid), Lactate Dehydrogenase (LDH), Lipase, Lithium, Magnesium, Phosphorus, Potassium, Protein-Total, Salicylate, Sodium, T3 Free, T3 Total, T4 Free, T4 Total, Thyroid Stimulating Hormone (TSH), Transferrin, Trighcerides. Urea Nitrogen, and Uric Acid on instruments listed in the expected values chart.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Richard Olson, C.P.A.
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K103364
§ 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.