(38 days)
The Audit™ MicroCV™ Immunoassay Linearity Set consists of five levels in Human and Bovine serum albumin matrix. Each level contains the following analytes: Cortisol, Digoxin, Estradiol, Ferritin, Folate, Free T4, FSH, hCG, LH, Progesterone, Prolactin, Testosterone, Total PSA, Total T3, Total T4, TSH, and Vitamin B12. 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 and to perform CLIA directed calibration verification for these same analytes with similar reagents on similar instrumentation in accordance with current CLIA-88 guidelines and regulations.
In addition, Level A – E of this product may be used as unassayed quality control material for these analytes or as an assayed quality control material for the analyzer systems specified in the package insert. It is not intended to be used as an assayed quality control material for any other analyzer systems.
The Audit™ MicroCV™ Immunoassay Linearity Set is a Human and Bovine serum albumin based, lyophilized, five level set of QC material, with each level containing 17 analytes It is used for proficiency testing in interlaboratory surveys and to perform CLIA directed calibration verification for the analytes listed using FDA accepted reagents for the appropriate instrumentation in accordance with current CLIA-88 guidelines and regulations. In apdrtions Level A ~ E of this product may be used as an unassayed quality control material for these analytes or as an assayed quality control material for the analyzer systems specified in the package insert. Where Level A is near the lower limit of instruments 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. It is not intended to be used as an assayed quality control material for any other analyzer systems.
The provided text describes the Audit™ MicroCV™ Immunoassay Linearity Set, a QC material used for verifying and validating the analytical measurement range for immunoassay testing methods. The information focuses on establishing substantial equivalence to a predicate device and product claims related to stability. It does not present acceptance criteria or detailed results of a study designed to prove the device meets specific performance criteria related to accuracy, precision, or comparison against a ground truth.
However, it does describe the stability studies performed, which can be interpreted as a form of performance evaluation for the claims made.
Here's an analysis based on the provided text, addressing the points where information is available and noting where it's absent:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria for performance beyond stability. The "reported device performance" is limited to stability claims.
| Acceptance Criteria (Implicit from Study) | Reported Device Performance |
|---|---|
| Reconstituted Stability should meet claim | 5 days at 2-8° C |
| Shelf Life should meet claim | 2 years, unopened at 2-8° C |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "stability studies have been performed," but does not detail the number of samples, batches, or replicates used in these studies.
- Data Provenance (e.g., country of origin of the data, retrospective or prospective): "All supporting data is retained on file at Aalto Scientific, Ltd." This implies the studies were conducted by the manufacturer, Aalto Scientific, Ltd., likely in the USA (where the company is based). The studies were prospective in nature, as they were conducted to support product claims for a new device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The study described is a stability study of the QC material itself, not a study evaluating diagnostic accuracy against patient samples or clinical outcomes. Therefore, there's no "ground truth" in the sense of expert-validated patient diagnoses.
4. Adjudication Method for the Test Set
Not applicable, as there is no diagnostic outcome being adjudicated.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This is a linearity set (QC material) for laboratory instruments, not an AI diagnostic device. Therefore, no MRMC study comparing human readers with or without AI assistance was conducted or would be applicable.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
Not applicable. This is a laboratory quality control material, not an algorithm or AI device.
7. The Type of Ground Truth Used
The "ground truth" in the context of stability studies for a linearity set refers to the expected stability profile of the analytes under specified conditions. This is established through internal testing and adherence to scientific principles of chemical and biochemical stability. For a linearity set, the "ground truth" would also refer to the accurate concentration assignment of the levels, which is done through a robust internal assay and manufacturing process, but this part of the study is not detailed.
8. The Sample Size for the Training Set
Not applicable. This is a quality control material, not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of device.
Summary of Device and Performance Information Provided:
The primary purpose of the document is to demonstrate substantial equivalence to a predicate device (Audit™ MicroCV™ General Chemistry Linearity Set, K042318) for regulatory approval (510(k)). The performance data presented focuses exclusively on the stability of the device:
- Device Name: Audit™ MicroCV™ Immunoassay Linearity Set
- Intended Use: To simulate human patient serum samples for verifying and validating the Analytical Measurement Range for non-waived immunoassay testing methods. Can also be used for proficiency testing and as unassayed/assayed quality control material.
- Key Performance Claims (from Stability Studies):
- Reconstituted Stability: 5 days when stored tightly capped at 2-8° C.
- Shelf Life: 2 years, when stored unopened at 2-8° C. (Note: Real-time studies are ongoing to support this claim).
- Matrix: Human and Bovine serum albumin based.
- Levels: Five levels (A-E) of lyophilized QC material, each containing 17 analytes (Cortisol, Digoxin, Estradiol, Ferritin, Folate, Free T4, FSH, hCG, LH, Progesterone, Prolactin, Testosterone, Total PSA, Total T3, Total T4, TSH, and Vitamin B12).
The document is a regulatory summary and, as such, focuses on demonstrating compliance and equivalence rather than a detailed scientific publication about a novel AI or diagnostic algorithm performance.
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KCX62668
510(k) Summary
A. Submitter
Aalto Scientific, Ltd. 1959 Kellogg Ave. Carlsbad, CA 92008 Telephone: (760) 431-7922 Fax: (760) 431-6824
OCT 16 2006
B. Contact Person
Alan Vekich Regulatory Affairs Specialist Telephone: (760) 431-7922 ext. 120 E-mail: avekich@aaltoscientific.com
C. Date of Summary Preparation
September 2006
D. Device Identification
| Product Trade Name: |
|---|
| Common Name: |
| Classification Name: |
| Device Classification: |
| Regulation Number: |
| Panel: |
| Product Code: |
Audit™ MicroCVTM Immunoassay Linearity Set Immunoassay Linearity Assay QC Material Class I 21 CFR 862.1660 75 JJY
E. Device to Which Substantial Equivalence is Claimed
Audit™ MicroCV™ General Chemistry Linearity Set Aalto Scientific, Ltd., Carlsbad, CA K042318
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F. Description of the Device
The Audit™ MicroCV™ Immunoassay Linearity Set is a Human and Bovine serum albumin based, lyophilized, five level set of QC material, with each level containing 17 analyters It is used for proficiency testing in interlaboratory surveys and to perform CLIA directed calibration verification for the analytes listed using FDA accepted reagents for the appropriate instrumentation in accordance with current CLIA-88 guidelines and regulations. In apdrtions Level A ~ E of this product may be used as an unassayed quality control material for these analytes or as an assayed quality control material for the analyzer systems specified in the package insert. Where Level A is near the lower limit of instruments 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. It is not intended to be used as an assayed quality control material for any other analyzer systems.
G. Statement of Intended Use
The Immunoassay Linearity Set is intended to simulate human patient serum samples for the purpose of verifying and validating the Analytical Measurement Range for non-waived immunoassay testing methods as identified in the package insert.
| Characteristics | Audit™ MicroCV™ ImmunoassayLinearity Set(New Device) | Audit™ MicroCV™ General ChemistryLinearity Set(K042318) |
|---|---|---|
| Intended Use | Linear, calibration verification qualitycontrol material | Linear, calibration verification qualitycontrol material |
| Number ofAnalytes per vial | 17 | 30 |
| Number of levelsper set | 5 | 5 |
| Contents | 5 x 5 mls | 5 x 5 mls |
| Matrix | Human and Bovine Serum Albumin | Human Based Serum |
| Type of Analytes | Immunoassay | General Chemistry |
| Form | Lyophilized | Lyophilized |
| Preservative | Yes | Yes |
| Storage | 2 to 8° CUntil expiration date | 2 to 8° CUntil expiration date |
| ReconstitutedStability | 5 days at 2 to 8° C | 7 days at 2 to 8° C except for enzymesand bilirubin, which are 48 hours |
H. Technical Characteristics Compared to Predicate Device
K062668 Pg 2 of 3
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I. Summary of Performance Data
Stability studies have been performed to determine the reconstituted stability and shelf life for the Audit™ MicroCV™ Immunoassay 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 5 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.
J. Conclusions
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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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Alan Vekich Regulatory Affairs Specialist Aalto Scientific, Ltd. 1959 Kellogg Ave. Carlsbad. CA 92008
OCT 1 6 2006
Re: K062668 Trade/Device Name: Audit™ MicroCV™ Immunoassay Linearity Set Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: September 8, 2006 Received: September 13, 2006
Dear Mr. Vekich:
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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section $10(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Alberto Gutz
Alberto Gutierrez, 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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Indications for Use
510(k) Number (if known): K 062 1268
Audit™ MicroCV™ Immunoassay Linearity Set Device Name:
Indications For Use:
The Audit™ MicroCV™ Immunoassay Linearity Set consists of five levels in Human and Bovine serum albumin matrix. Each level contains the following analytes: Cortisol, Digoxin, Estradiol, Ferritin, Folate, Free T4, FSH, hCG, LH, Progesterone, Prolactin, Testosterone, Total PSA, Total T3, Total T4, TSH, and Vitamin B12. 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 and to perform CLIA directed calibration verification for these same analytes with similar reagents on similar instrumentation in accordance with current CLIA-88 guidelines and regulations.
In addition, Level A – E of this product may be used as unassayed quality control material for these analytes or as an assayed quality control material for the analyzer systems specified in the package insert. It is not intended to be used as an assayed quality control material for any other analyzer systems.
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)
§ 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.