(286 days)
The Audit™ MicroCVTM Homocysteine Linearity Set is assayed quality control material consisting of five levels human based serum. Each level contains Homocysteine analyte. The five levels demonstrate a linear relationship to each other for Homocysteine analyte. It is intended to simulate human patient serum samples for purpose of determining linearity, calibration verification and verification of reportable range for Homocysteine. The product is intended for use with quantitative assays on the indicated analyzer provided in the labeling. The Audit™ MicroCVTM Homocysteine Linearity Set should not be used for calibration or standardization of the Homocysteine assay. The Audit™ MicroCV™ Homocysteine Linearity Set is "For In Vitro Diagnostic Use Only".
The Audit™ MicroCV™ Homocysteine Linearity Set is a human based, liquid, five level set of QC material, with each level containing one analyte: Homocysteine. It is used to confirm the proper calibration, linear operating range, and reportable range of Homocysteine. Level A has concentration near the lower limit level and Level E has concentrations near the upper limit level of instruments. Levels B - D are related by linear dilution of Level A and Level E.
The provided document describes a 510(k) premarket notification for the "Audit™ MicroCV™ Homocysteine Linearity Set." This device is a quality control material intended to verify linearity, calibration, and reportable range for Homocysteine assays. The primary focus of the document is to demonstrate substantial equivalence to predicate devices, rather than an extensive study proving the device meets specific acceptance criteria through a clinical trial.
Therefore, many of the requested elements (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this type of submission for a quality control material.
However, the document does provide information related to the device's performance through stability studies, which are crucial for a quality control product.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
For the Audit™ MicroCV™ Homocysteine Linearity Set, the key performance aspects are stability. The acceptance criteria for stability would be that the Homocysteine analyte remains stable within specified storage conditions for defined periods. The reported performance suggests these criteria were met.
| Acceptance Criteria Category | Specific Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Stability (Open Vial) | Homocysteine stable for a specified duration when stored at 2-8°C, capped. | 10 days when stored tightly capped at 2 - 8° C. |
| Stability (Shelf Life) | Homocysteine stable for a specified duration when stored unopened at 2-8°C. | Two years, when stored unopened at 2 - 8° C. (Real-time studies ongoing) |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not directly applicable in the context of a 510(k) for a QC material. The "test set" here refers to samples used in stability studies. The document states "All supporting data is retained on file at Aalto Scientific, Ltd.," but does not specify the number of individual vials or batches tested for stability.
- Data Provenance: The studies were performed by Aalto Scientific, Ltd. The document does not specify the country of origin of the data beyond the company's location (Carlsbad, CA). The studies are inherent to the product development and are effectively prospective with respect to determining product stability claims, although the testing itself retrospectively assesses manufactured lots.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable. For a quality control material, the "ground truth" for linearity and analyte concentration is established by the manufacturer through their validated assay methods and manufacturing processes, not by external experts reviewing test results.
4. Adjudication method for the test set
- Not applicable as there is no independent ground truth review or adjudication process described for the performance of a QC material. Performance is assessed against internal specifications and validated analytical methods.
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 device is an in vitro diagnostic quality control material, not an AI-powered diagnostic tool requiring human reader studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a reagent for laboratory testing, not an algorithm.
7. The type of ground truth used
- For the Audit™ MicroCV™ Homocysteine Linearity Set, the "ground truth" (or reference values) for Homocysteine concentrations in the linearity levels are established by the manufacturer's validated analytical methods and manufacturing control processes. The claim of linearity is derived from the controlled dilution of known concentrations.
8. The sample size for the training set
- Not applicable. There is no machine learning model or "training set" in the context of this traditional IVD quality control device.
9. How the ground truth for the training set was established
- Not applicable for the same reason as point 8.
Summary of the Study Proving Acceptance Criteria:
The document briefly mentions "Stability studies have been performed to determine the open vial stability and shelf life for the Audit™ MicroCV™ Homocysteine Linearity Set." These studies, which are not detailed in this summary, would involve:
- Methodology: Testing multiple batches of the product under specified storage conditions (e.g., 2-8°C, tightly capped for open vial; 2-8°C unopened for shelf life). Samples would be analyzed for Homocysteine concentration at defined time points using a validated analytical method (e.g., an enzymatic assay or HPLC, typically the method the QC material is intended for).
- Acceptance Criteria for Stability Studies: The Homocysteine concentration measured at various time points within the specified storage conditions must remain within predefined acceptable limits (e.g., ±X% of the initial concentration or within a certain confidence interval) to support the claims of 10-day open vial stability and 2-year shelf life.
- Data: The document states, "All supporting data is retained on file at Aalto Scientific, Ltd." This indicates that comprehensive results from these stability studies exist, showing that the product met these internal acceptance criteria for stability.
- Ongoing Studies: The note "Real time studies are ongoing to support the shelf life of this product" indicates a standard regulatory practice where accelerated stability data might initially support a shelf life claim, but real-time studies continuously confirm it over the product's full intended shelf life.
In conclusion, the performance of this device, a quality control material, is primarily demonstrated through rigorous internal stability studies, not through external clinical trials or expert-adjudicated test sets as would be the case for a diagnostic device that interprets patient data. The summary provided here focuses on the outcome of these studies (the stated stability claims) rather than the detailed experimental design.
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DEC 2 3 2010
510(k) Summary
A. Submitter
Aalto Scientific, Ltd. 1959 Kellogg Ave. Carlsbad, CA 92008 Telephone: (760) 431-7922 Fax: (760) 431-6824
B. Contact Person
Dessi Lyakov Telephone: (760) 431-7922 Ext. 118 E-mail: dlyakov@aaltoscientific.com
C. Date of Summary Preparation
December 23, 2010
D. Device Identification
Product Trade Name: Common Name: Classification Name: Device Classification: Regulation Number: Panel: Product Code:
Audit™ MicroCVTM Homocysteine Linearity Set Homocysteine Linearity Set Assay QC Material Class I 21 CFR 862.1660 75 JJX
E. Device to Which Substantial Equivalence is Claimed
Product Trade Name:
Liquichek Homocysteine Control Bio-Rad Laboratories, Irvine, California K984071
Audit MicroCV General Chemistry Linearity Set Aalto Scientific, Ltd., Carlsbad, California K042318
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Description of the Device
The Audit™ MicroCV™ Homocysteine Linearity Set is a human based, liquid, five level set of QC material, with each level containing one analyte: Homocysteine. It is used to confirm the proper calibration, linear operating range, and reportable range of Homocysteine. Level A has concentration near the lower limit level and Level E has concentrations near the upper limit level of instruments. Levels B - D are related by linear dilution of Level A and Level E.
Statement of Intended Use
The Audit™ MicroCVTM Homocysteine Linearity Set is assayed quality control material consisting of five levels human based serum. Each level contains Homocysteine analyte. The five levels demonstrate a linear relationship to each other for Homocysteine analyte. It is intended to simulate human patient serum samples for purpose of determining linearity, calibration verification and verification of reportable range for Homocysteine. The product is intended for use with quantitative assays on the indicated analyzer provided in the labeling. The Audit™ MicroCVTM Homocysteine Linearity Set should not be used for calibration or standardization of the Homocysteine assay. The Audit™ MicroCV™ Homocysteine Linearity Set is "For In Vitro Diagnostic Use Only".
I. Summary of Performance Data
Stability studies have been performed to determine the open vial stability and shelf life for the Audit™ MicroCVTM Homocysteine Linearity Set. All supporting data is retained on file at Aalto Scientific, Ltd. Product claims are as follows:
Open Vial Stability: Once a vial has been opened. Homocysteine will be stable for 10 days when stored tightly capped at 2 - 8° C.
Shelf Life: Two years, when stored unopened at 2 - 8° C,
Note: Real time studies are ongoing to support the shelf life of this product.
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H. Technical Characteristics Compared to Predicate Device
| Audit™ MicroCV™ | Bio-Rad Liquichek | Audit™ MicroCV™ General | |
|---|---|---|---|
| Characteristics | Homocysteine Linearity Set | Homocysteine Control (K984071) | Chemistry Linearity Set(K042318) |
| Intended Use | The Audit™ MicroCV™Homocysteine Linearity Set isassayed quality controlmaterial consisting of fivelevels human based serum.Each level containsHomocysteine analyte. Thefive levels demonstrate alinear relationship to eachother for Homocysteineanalyte. It is intended tosimulate human patient serumsamples for purpose ofdetermining linearity,calibration verification andverification of reportablerange for Homocysteine. Theproduct is intended for usewith quantitative assays on theindicated analyzer provided inthe labeling. The Audit™MicroCV™ HomocysteineLinearity Set should not beused for calibration orstandardization of theHomocysteine assay. TheAudit™ MicroCV™Homocysteine Linearity Set is"For In Vitro Diagnostic UseOnly". | A liquid control formonitoringhomocysteine testprocedures. Thisproduct can be usedfor methods such asHPLC and automatedimmunoassay. | Audit™ MicroCV™ GeneralChemistry Linearity Set is assayedquality control material consisting ofhuman based serum. It is intended tosimulate human patient serum samplesfor the purpose of monitoring theprecision and to detect systematicanalytical deviations of laboratorytesting procedures. This product mayalso be used as unassayed qualitycontrol material for these sameanalytes. |
| Number ofAnalytes per vial | 1 | 1 | 31 |
| Number of levelsper set | 5 | 2 | 5 |
| ContentsMatrix | 5 x 1mLHuman Serum | 6 x 1mLHuman Serum | 5 x 5 mLHuman Serum |
| Type of Analytes | Homocysteine | Homocysteine | Total Protein, Albumin, AlkalinePhosphatase, ALT, Amylase, AST,Bilirubin (Total and Direct), BUN,Calcium, Chloride, Cholesterol, CO2,Creatine Kinase, Creatinine, Gamma-GT, Glucose, HDL Cholesterol, Iron,LDH, LDL Cholesterol, Lactate,Lipase, Magnesium, Phosphorus,Potassium, Sodium, Total Protein, |
| Form | Liquid | Liquid | Lyophilized |
| Storage | 2 to 8° Cfor 24 months | -10 to -70° Cfor 36 months | 2 to 8° C for 24 months |
| Open BottleStability | 10 days at 2 to 8° C | 14 days at 2 to 8° C | 7 days at 2 to 8° C |
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Based upon the purpose of the device, the descriptions and labeling of the predicate device, the safety and efficacy, and the stability data generated, the product is substantially equivalent to the predicate device.
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Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
AALTO Scientific LTD. c/o Ms. Dessi Lyakov Manager, Regulatory Affairs 1959 Kellogg Avenue Carlsbad, CA 92008
DEC 2 3 2010
Re: K100715
Trade Name: Audit™ MicroCV™ Homocysteine Linearity Set Regulation Number: 21 CFR §862.1660 Regulation Name: Quality control material (assayed and unassayed). Regulatory Class: Class I, reserved Product Codes: JJX Dated: November 22, 2010 Received: November 23, 2010
Dear Ms. Lyakov:
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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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 premarket notification" (21 CFR 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 toll 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,
CJC.
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
Enclosure
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DEC 2 3 2010
510(k) Number: K100715
Device Name: Audit™ MicroCV™ Homocysteine Linearity Set
Indications For Use:
The Audit™ MicroCVTM Homocysteine Linearity Set is assayed quality control material consisting of five levels human based serum. Each level contains Homocysteine analyte. The five levels demonstrate a linear relationship to each other for Homocysteine analyte. It is intended to simulate human patient serum samples for purpose of determining linearity, calibration verification and verification of reportable range for Homocysteine. The product is intended for use with quantitative assays on the indicated analyzer provided in the labeling. The Audit™ MicroCVTM Homocysteine Linearity Set should not be used for calibration or standardization of the Homocysteine assay. The Audit™ MicroCV™ Homocysteine Linearity Set is "For In Vitro Diagnostic Use Only".
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 IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol Benson
Sign-Off
്ചാ of In Vitro Diagnostic Device -tion and Safety
§ 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.