(259 days)
The Audit™ MicroCV™ Protein Linearity is assayed quality control material consisting of five levels protein (human) based serum. Each level contains Alpha-1-Antitrypsin, Complement C3, Complement C4, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M and Transferrin analytes. The five levels demonstrate a linear relationship to each other for Alpha-1-Antitrypsin, Complement C3, Complement C4, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M, and Transferrin analytes. It is intended to simulate human patient serum samples and to detect systematic analytical deviations of laboratory testing procedures for Alpha-1-Antitrypsin, Complement C3, Complement C4, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M, and Transferrin. The product is intended for use with quantitative assays on the indicated analyzer provided in the labeling. The Audit MicroCV Protein Linearity Set is "For In Vitro Diagnostic Use Only."
The Audit™ MicroCVTM Protein Linearity Set is a human based, five level set of QC material, with each level containing seven analytes: Aipha-1-Antitrypsin, Complement C3, Complement C4, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M, and Transferrin. It is used to confirm the proper calibration, linear operating range, and reportable range of 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.
The provided text describes a 510(k) premarket notification for a medical device called the Audit™ MicroCV™ Protein Linearity Set. The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance data in the format requested.
Here's an attempt to extract and infer the information based on the provided text, while acknowledging that many fields cannot be fully populated as they are not explicitly stated in the 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state numerical acceptance criteria for a study comparing the device's performance against a standard or ground truth. Instead, it asserts "substantial equivalence" to a predicate device based on similar intended use and technical characteristics, and verifies stability claims.
| Acceptance Criteria (Inferred from intended use and stability claims) | Reported Device Performance (Summary) |
|---|---|
| Intended Use: Device demonstrates linear relationship for specified analytes and detects systematic analytical deviations. | The device consists of five levels that demonstrate a linear relationship for Alpha-1-Antitrypsin, Complement C3, Complement C4, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M, and Transferrin analytes. It is intended to simulate human patient serum samples and to detect systematic analytical deviations. |
| Open Vial Stability: All analytes stable for 1 day when stored tightly capped at 2 - 8° C. | Stability studies performed to determine open vial stability. "All supporting data is retained on file." Claims: 1 day stability at 2 - 8° C. |
| Shelf Life: One year when stored unopened at 2 - 8° C. | Stability studies performed to determine shelf life. "All supporting data is retained on file." Claims: 1 year shelf life at 2 - 8° C. "Real time studies are ongoing to support the shelf life." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of a clinical or performance study where individual samples were analyzed and results compared to a ground truth. The performance data primarily refers to stability studies.
- Sample Size for Test Set: Not specified. The linearity set itself contains "five levels" of QC material.
- Data Provenance: Not explicitly stated, but the stability studies were "performed" by Aalto Scientific, Ltd. The base material is "human based serum." The document does not indicate country of origin for any data or if it was retrospective or prospective beyond the mention of "real time studies are ongoing" for shelf life.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Falls under the same category as point 2. There is no mention of experts establishing ground truth for a test set in the context of this 510(k) submission. The device itself serves as a quality control material to verify instrument linearity.
- Number of Experts: Not applicable/not specified.
- Qualifications of Experts: Not applicable/not specified.
4. Adjudication Method for the Test Set
Not applicable, as a test set and associated adjudication method are not described in this submission.
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 a linearity set (quality control material) for in vitro diagnostic assays, not an AI-assisted diagnostic tool for 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
For a linearity set, the "ground truth" is typically established by the manufacturer during the formulation process, ensuring that the five levels are prepared to specific concentrations that demonstrate a linear relationship. This is an intrinsic characteristic of the product's design. The clinical utility is in its ability to aid in verifying the linearity of an analytical instrument by acting as a known linear standard.
- Type of Ground Truth: The linearity and analyte concentrations are inherent properties of the manufactured quality control material, established during its production and characterization by the manufacturer (Aalto Scientific, Ltd., in this case). It relies on the precise formulation and measurement against traceable standards during its development.
8. The Sample Size for the Training Set
Not applicable. This device is a quality control material, not a machine learning model.
9. How the Ground Truth for the Training Set was Established
Not applicable.
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K101Z16
510(k) Summary
A. Submitter
JAN 1 4 2011
く
Aalto Scientific, Ltd. 1959 Kellogg Ave. Carlsbad, CA 92008 (760) 431-7922 Telephone: (760) 431-6824 Fax:
B. Contact Person
E-mail: Dessi Lyakov Telephone: (760) 431-7922 Ext. 118 E-mail: dlyakov(@aaltoscientific.com
C. Date of Summary Preparation
December 03, 2010
D. Device Identification
Product Trade Name: Common Name: Classification Name: Device Classification: Regulation Number: Panel: Product Code:
Audit™ MicroCVTM Protein Linearity Set Protein 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 Protein Linearity Set is a human based, five level set of QC material, with each level containing seven analytes: Aipha-1-Antitrypsin, Complement C3, Complement C4, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M, and Transferrin. It is used to confirm the proper calibration, linear operating range, and reportable range of 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 Audit™ MicroCV™ Protein Linearity is assayed quality control material consisting of five levels protein (human) based serum. Each level contains Alpha-1-Antitrypsin, Complement C3. Complement C4, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M and Transferrin analytes. The five levels demonstrate a linear relationship to each other for Alpha-1-Antitrypsin, Complement C3, Complement C4, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M, and Transferrin analytes. It is intended to simulate human patient serum samples and to detect systematic analytical deviations of laboratory testing procedures for Alpha-1-Antitrypsin. Complement C3, Complement C4, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M, and Transferrin. The product is intended for use with quantitative assays on the indicated analyzer provided in the labeling. The Audit MicroCV Protein 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 Protein 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, all analytes will be stable for 1 day when stored tightly capped at 2 - 8° C.
Shelf Life: One year, 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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| Characteristics | Audit™ MicroCV™ Protein LinearitySet(K101216) | Audit™ MicroCV™ General ChemistryLinearity Set(K042318) |
|---|---|---|
| Intended Use | The Audit™ MicroCV™ ProteinLinearity is assayed quality controlmaterial consisting of five levelsprotein (human) based serum. Eachlevel contains Alpha-1-Antitrypsin,Complement C3, Complement C4,Immunoglobulin G, ImmunoglobulinA, Immunoglobulin M andTransferrin analytes. The five levelsdemonstrate a linear relationship toeach other for Alpha-1-Antitrypsin,Complement C3, Complement C4,Immunoglobulin G, ImmunoglobulinA, Immunoglobulin M, andTransferrin analytes. It is intended tosimulate human patient serumsamples and to detect systematicanalytical deviations of laboratorytesting procedures for Alpha-1-Antitrypsin, Complement C3,Complement C4, Immunoglobulin G,Immunoglobulin A, ImmunoglobulinM, and Transferrin. The product isintended for use with quantitativeassays on the indicated analyzerprovided in the labeling. The AuditMicroCV Protein Linearity Set is"For In Vitro Diagnostic Use Only." | Audit™ MicroCV™ General ChemistryLinearity Set is assayed quality controlmaterial consisting of human basedserum. It is intended to simulate humanpatient serum samples for the purposeof monitoring the precision and todetect systematic analytical deviationsof laboratory testing procedures. Thisproduct may also be used as unassayedquality control material for these sameanalytes. |
| Number ofAnalytes per vial | 7 | 30 |
| Number oflevels per set | 5 | 5 |
| Contents | 5 x 2 mL | 5 x 5 mL |
| Matrix | Human Based Serum | Human Based Serum |
| Type ofAnalytes | Clinical Chemistry | General Chemistry |
:
H. Technical Characteristics Compared to Predicate Device
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| Form | Liquid | Lyophilized |
|---|---|---|
| Stabilizers | None | None |
| Preservatives | Sodium Azide | SorbitolSodium azide |
| Storage | 2 to 8° CUntil expiration date | 2 to 8° CUntil expiration date |
| Open BottleStability | 24 hours at 2 to 8° C | 24 hours at 2 to 8° C |
:
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:
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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
Silver Spring, MD 20993
Food and Drug Administration
10903 New Hampshire Avenue
Image /page/5/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features an eagle with its wings spread, symbolizing the federal government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Aalto Scientific c/o Dessi Lyakov 1959 Kellogg Ave. Carlsbad. CA 92008
Re: K101216
Trade Name: Audit Micro CV Protein Linearity Set Regulation Number: 21 CFR §862.1660 Regulation Name: Quality Control. Regulatory Class: Class I, reserved Product Codes: JJY Dated: December 3, 2010 Received: December 7, 2010
JAN 1 4 20:1
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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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 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.
GJC.
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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Indications for Use
510(k) Number: ¥10126
Device Name: Audit™ MicroCV Protein Linearity Set
Indications For Use:
The Audit™ MicroCV™ Protein Linearity is assayed quality control material consisting of five levels protein (human) based serum. Each level contains Alpha-1-Antitrypsin, Complement C3, Complement C4, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M and Transferrin analytes. The five levels demonstrate a linear relationship to each other for Alpha-1-Antitrypsin, Complement C3, Complement C4, Immunoglobulin A, Immunoglobulin A, Immunoglobulin M, and Transferrin analytes. It is intended to simulate human patient serum samples and to detect systematic analytical deviations of laboratory testing procedures for Alpha-1-Antitrypsin, Complement C3, Complement C4, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M, and Transferrin. The product is intended for use with quantitative assays on the indicated analyzer provided in the labeling. The Audit MicroCV Protein Linearity Set is "For In Vitro Diagnostic Use Only."
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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)
Signature
Division Sign-Off Office of In Vitro Diagnostic Devices Evaluation and Safety
510(k) K101216
Aalto Scientific, Ltd. 510(k) Notification Audit™ MicroCVTM Protein Linearity Set
§ 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.