(43 days)
The Audit™ MicroCV™ Tumor Markers Linearity Set is intended to simulate human patient serum samples for the purpose of verifying and validating the Analytical Measurement Range for non-waived turnor marker testing methods as identified in the package insert.
The Audit™ MicroCV™ Tumor Markers Linearity Set consists of five levels in Human based serum. Each level contains the following analytes: Alpha fetoprotein (AFP), Carcinoembryonic antigen (CEA), CA 125, CA 15-3, Prostate specific antigen-free (free PSA), total PSA. The five levels demonstrate a linear relationship to each other for their respective analytes, reagents, and instruments. This product may be used for proficiency testing in interlaboratory surveys.
The Audit™ MicroCVTM Tumor Markers Linearity Set is a human based, lyophilized, five level set of QC material, with each level containing 6 analytes. It is used to confirm the proper calibration, linear operating range, and reportable range of Tumor Marker methods for the analytes listed. Level A is near the lower limit level and Level E has concentrations near the upper limit of instruments. Levels B - D are related by linear dilution of Level A and Level E.
This document is a 510(k) summary for the Audit™ MicroCV™ Tumor Markers Linearity Set, a quality control material. It describes the device, its intended use, and claims substantial equivalence to another legally marketed device. However, it does not contain the detailed study information typically found in a clinical study report that would address many of the questions asked.
Based on the provided text, here is the information available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance Statement |
|---|---|
| Reconstituted Stability Analyte Stability | All analytes stable for 7 days when stored tightly capped at 2 - 8° C. |
| Shelf Life (Unopened) | Two years, when stored unopened at 2 - 8° C. |
| Linearity Relationship between 5 levels | The five levels demonstrate a linear relationship to each other for their respective analytes, reagents, and instruments. (This is an indication of use/claim, not detailed performance data found in this summary). |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not specified. The document states "Stability studies have been performed to determine the reconstituted stability and shelf life for the Audit™ MicroCV™ Tumor Markers Linearity Set. All supporting data is retained on file at Aalto Scientific, Ltd." It does not provide details of the sample size used in these studies.
- Data Provenance: Not specified. It's implied the studies were conducted by Aalto Scientific, Ltd. but no information on country of origin or whether the data was retrospective or prospective is given, other than "Real time studies are ongoing to support the shelf life of this product," which implies prospective data collection for shelf life.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: Not applicable. This device is a linearity set for quality control of analytical instruments, not a diagnostic device requiring expert interpretation of results to establish ground truth for a test set. The "ground truth" here would relate to the known concentrations or linearity of the materials themselves, which are manufactured to specific specifications.
- Qualifications of experts: Not applicable.
4. Adjudication method for the test set
- Adjudication method: Not applicable. This is not a study that involves human interpretation of results requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- MRMC study: No. This is not a diagnostic device that would typically involve an MRMC study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone performance: Not applicable. This is a linearity quality control material, not an algorithm or software. The "performance" relates to the stability and linearity characteristics of the material itself.
7. The type of ground truth used
- Type of ground truth: The "ground truth" for this linearity set would be the pre-defined, manufactured concentrations of the analytes at each of the five levels, and the expected linear relationship between these levels. These values are established during the manufacturing and characterization process of the QC material against reference methods or calibrators. The document states it is "human based," referring to the serum matrix, but not to human interpretation as ground truth.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This device is a quality control material and does not use a "training set" in the context of machine learning or classification algorithms.
9. How the ground truth for the training set was established
- Ground truth for training set: Not applicable (as above).
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510(k) Summary
OCT 3 0 2008
A. Submitter
Aalto Scientific, Ltd. 1959 Kellogg Ave. Carlsbad, CA 92008 Telephone: (760) 431-7922 Fax: (760) 431-6824
B. Contact Person
Brandon J Percz Telephone: (760) 431-7922 Ext. 120 E-mail: bperez@aaltoscientific.com
C. Date of Summary Preparation
September 15, 2008
D. Device Identification
Product Trade Name: Common Name: Classification Name: Device Classification: Regulation Number: Panel: Product Code:
Audit™ MicroCVIM Tumor Markers Linearity Set Tumor Markers Linearity Assay QC Material Class I 21 CFR 862.1660 75 JJY
E. Device to Which Substantial Equivalence is Claimed
Audit™ MicroCVTM General Chemistry Linearity Set Aalto Scientific, Ltd., Carlsbad, CA K042318
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F. Description of the Device
The Audit™ MicroCVTM Tumor Markers Linearity Set is a human based, lyophilized, five level set of QC material, with each level containing 6 analytes. It is used to confirm the proper calibration, linear operating range, and reportable range of Tumor Marker methods for the analytes listed. Level A is near the lower limit level and Level E has concentrations near the upper limit of instruments. Levels B - D are related by linear dilution of Level A and Level E.
G. Statement of Intended Use
The Tumor Markers Linearity Set is intended to simulate human patient serum samples for the purpose of verifying and validating the Analytical Measurement Range for non-waived turnor marker testing methods as identified in the package insert.
1. Summary of Performance Data
Stability studies have been performed to determine the reconstituted stability and shelf life for the Audit™ MicroCV™ Tumor Markers Linearity Set. All supporting data is retained on file at Aalto Scientific, Ltd. Product claims are as follows:
Reconstituted Stability: Once a vial has been reconstituted, all analytes will be stable for 7 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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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the top half of the seal.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Aalto Scientific Ltd. C/O Brandon J. Perez 1959 Kellogg Avenue Carlsbad, CA 92008
OCT 3 0 2008
Re: K082717 Trade/Device Name: Audit™ MicroCVTM Tumor Markers Linearity Set Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (assayed and unassayed) Regulatory Class: I Product Code: JJY Dated: September 16, 2008 Received: September 18, 2008
Dear Mr. Perez
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally
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marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-JSee Below For Phone Numbers]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Maria M. Chan, Ph.D.
Acting Director
ision of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K082717
Device Name: Audit™ MicroCV™ Tumor Markers Linearity Set
Indications For Use:
The Audit™ MicroCV™ Tumor Markers Linearity Set consists of five levels in Human based serum. Each level contains the following analytes: Alpha fetoprotein (AFP), Carcinoembryonic antigen (CEA), CA 125, CA 15-3, Prostate specific antigen-free (free PSA), total PSA. The five levels demonstrate a linear relationship to each other for their respective analytes, reagents, and instruments. This product may be used for proficiency testing in interlaboratory surveys.
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)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K0827/7
§ 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.