(62 days)
The Audit™ MicroCV™ Procalcitonin Linearity Set is assayed quality control material consisting of five levels of Procalcitonin analyte in bovine serum albumin. The five levels demonstrate a linear relationship to each other for the Procalcitonin analyte. It is intended to simulate human patient serum samples for the purpose of monitoring the precision and to detect systematic analytical deviations of laboratory testing procedures for Procalcitonin. This product may be used as an assayed quality control material for Procalcitonin analyte.
The Audit™ MicroCV™ Procalcitonin Linearity Set is a bovine serum albumin, freeze dried, five level set of QC material, with each level containing one analyte: Procalcitonin. It is used to confirm the proper calibration, linear operating range, and reportable range of Procalcitonin. 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) summary for the Audit™ MicroCV™ Procalcitonin Linearity Set, a quality control material. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria for a new clinical diagnostic device. Therefore, much of the requested information regarding clinical studies, sample sizes, expert ground truth, and comparative effectiveness is not applicable or available in this specific document.
However, based on the information provided, here's a breakdown of what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state quantitative acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) like a diagnostic device would. Instead, the "performance" here relates to the stability of the QC material, and the acceptance is based on demonstrating substantial equivalence to a predicate device for its intended use.
| Acceptance Criterion (Implicit based on product claims) | Reported Device Performance (Summary) |
|---|---|
| Open Vial Stability | Procalcitonin analyte is stable for 5 days when stored tightly capped at 2-8°C. |
| Shelf Life | One year at 2-8°C. (Real-time studies ongoing) |
| Linear Relationship | The five levels of Procalcitonin demonstrate a linear relationship to each other. |
| Substantial Equivalence to Predicate | Determined to be substantially equivalent to K042318 based on technical characteristics, intended use, and stability data. |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a "test set" in the context of clinical performance evaluation using patient samples. The device is a quality control material. The stability studies carried out would involve batches of the QC material.
- Sample Size: Not specified in terms of clinical samples. Stability studies would have used multiple units/batches of the QC material.
- Data Provenance: Not explicitly stated as "country of origin" for clinical data. The studies were performed internally by Aalto Scientific, Ltd. (Carlsbad, CA, USA). The studies are "real-time studies," which indicates a prospective data collection for stability.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. As this is a quality control material, the "ground truth" for its performance relates to its chemical stability and linearity, which are evaluated through laboratory-based analytical methods rather than expert clinical consensus.
4. Adjudication Method for the Test Set
Not applicable. There is no "test set" requiring clinical adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This is a quality control material, not a diagnostic device requiring MRMC studies for human reader performance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This is a laboratory reagent, not an algorithm.
7. The Type of Ground Truth Used
For the stability and linearity claims:
- Ground Truth: Laboratory analytical measurements (e.g., spectrophotometry, immunoassay to quantify Procalcitonin concentrations) performed on the QC material over time and across different dilutions. These measurements are typically compared against established analytical standards and internal specifications to confirm stability and linearity.
8. The Sample Size for the Training Set
Not applicable. This device is a quality control material and does not involve machine learning or a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this device.
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K1014634
510(k) Summary
A. Submitter
FDA CDRH DMC
JUL 22 2010
Received
Aalto Scientific, Ltd. 1959 Kellogg Ave. Carlsbad, CA 92008 Telephone: (760) 431-7922 (760) 431-6824 Fax:
B. Contact Person
Dessi Lyakov Telephone: (760) 431-7922 Ext. 118 E-mail: dlyakov@aaltoscientific.com
C. Date of Summary Preparation
May 18, 2010
D. Device Identification
Product Trade Name: Common Name: Classification Name: Device Classification: Regulation Number: Panel: Product Code:
Audit™ MicroCVTM Procalcitonin Linearity Set Procalcitonin Linearity Assay QC Material Class I 21 CFR 862.1660 83 MJX
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™ Procalcitonin Linearity Set is a bovine serum albumin, freeze dried, five level set of QC material, with each level containing one analyte: Procalcitonin. It is used to confirm the proper calibration, linear operating range, and reportable range of Procalcitonin. 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.
G. Statement of Intended Use
The Audit™ MicroCV™ Procalcitonin Lincarity Set is assayed quality control material consisting of five levels of Procalcitonin analyte in bovine serum albumin. The five levels demonstrate a linear relationship to each other for the Procalcitonin analyte. It is intended to simulate human patient serum samples for the purpose of monitoring the precision and to detect systematic analytical deviations of laboratory testing procedures for Procalcitonin. This product may be used as an assayed quality control material for Procalcitonin analyte.
I. Summary of Performance Data
Stability studies have been performed to determine the shelf life for the Audit™ MicroCVTM Procalcitonin 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 reconstituted, Procalcitonin analyte will be stable for 5 days when stored tightly capped at 2-8 C.
· Shelf Life: One year 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
| Characteristics | Audit™ MicroCV™ ProcalcitoninLinearity Set(New Device) | Audit™ MicroCV™ General ChemistryLinearity Set(K042318) |
|---|---|---|
| Intended Use | The Audit™ MicroCV™ ProcalcitoninLinearity Set is assayed quality controlmaterial consisting of five levels ofProcalcitonin analyte in bovine serumalbumin. The five levels demonstrate alinear relationship to each other for theProcalcitonin analyte. It is intended tosimulate human patient serum samplesfor the purpose of monitoring theprecision and to detect systematicanalytical deviations of laboratory testingprocedures for Procalcitonin. Thisproduct may be used as an assayedquality control material for Procalcitoninanalyte. | Audit™ MicroCV™ General ChemistryLinearity Set is assayed quality controlmaterial consisting of human basedserum. It is intended to simulate humanpatient serum samples for the purpose ofmonitoring the precision and to detectsystematic analytical deviations oflaboratory testing procedures. Thisproduct may also be used as unassayedquality control material for these sameanalytes. |
| Number ofAnalytes per vial | 1 | 30 |
| Number of levelsper set | 5 | 5 |
| Contents | 5 x 1 mL | 5 x 5 mL |
| Matrix | Bovine Serum Albumin | Human Based Serum |
| Type of Analytes | Clinical Chemistry | General Chemistry |
| Form | Lyophilized | Lyophilized |
| Stabilizers | None | None |
| Preservatives | Sodium azide | SorbitolSodium azide |
| Storage | 2 to 8° CUntil expiration date | 2 to 8° CUntil expiration date |
| Open VialStability | 5 days at 2-8 C | 7 days at 2 to 8° C except for enzymesand bilirubin |
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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 cquivalent to the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
JUL 2 2 2010
Aalto Scientific, Ltd c/o Dessi Lyakov Manager, Regulatory Affairs 1959 Kellogg Ave Carlsbad, CA 92008
Re: K101434
Trade/Device Name: Audit™Micro CV™Procalcitonin Linearity Set Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (assayed and unassayed) Regulatory Class: Class I Product Code: MJX Dated: May 21, 2010 Received: May 24, 2010
Dear Mr. 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 class II (Special Controls), 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 Parts 801 and 809); medical device reporting of medical device-related adverse events) (21 CFR 803); 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
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Page 2 - Dessi Lyakov
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 1030. This letter will and in your 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 advice for your device on our labeling regulation (21 CFR Part 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,
Sally atzps
Sally A. Hojvat, M.Sc., Ph.D Director Division of Microbiology 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): unknown k 1614 3 4
Device Name: Audit™ MicroCV™ Procalcitonin Linearity Set
Indications For Use:
The Audit™ MicroCV™ Procalcitonin Linearity Set is assayed quality control material consisting of five levels of Procalcitonin analyte in bovine scrum albumin. The five levels demonstrate a linear relationship to each other for the Procalcitonin analyte. It is intended to simulate human patient serum samples for the purpose of monitoring the precision and to detect systematic analytical deviations of laboratory testing procedures for Procalcitonin. This product may be used as an assayed quality control material for Procalcitonin analyte.
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)
fory arts
Division Sign-Off
Office of In Vitro Dlagnos Device Evaluation and Safety
510k
§ 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.