(216 days)
The Audit™ MicroCV™ hs-CRP Linearity Set is assayed quality control material consisting of five levels human based serum. Each level contains High Sensitivity C-Reactive Protein (hs -CRP) analyte. The five levels demonstrate a linear relationship to each other for High Sensitivity C-Reactive Protein (hs -CRP) analyte. It is intended to simulate human patient serum samples for purpose of monitoring and detecting systematic analytical deviations of laboratory testing procedures for High Sensitivity C-Reactive Protein (hs -CRP). This product may be used as quality control material for High Sensitivity C-Reactive Protein (hs -CRP) analyte. When used for quality control purposes, it is recommended that each laboratory establish its own means and acceptable ranges and use the values provided only as guides. The product is intended for use with quantitative assays on the indicated analyzer provided in the labeling. The Audit™ MicroCVTM hs-CRP Linearity Set is "For In Vitro Diagnostic Use Only".
The Audit™ MicroCVTM hs-CRP Linearity Set is a human based, liquid, five level set of QC material, with each level containing one analyte: High Sensitivity C-Reactive Protein (hs -CRP). It is used to confirm the proper calibration, linear operating range, and reportable range of hs-CRP. 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 does not contain explicit acceptance criteria and a study to prove the device meets these criteria in the typical format of a medical device performance study (e.g., accuracy, sensitivity, specificity). Instead, the document describes a quality control material and its stability.
Here's an analysis based on the information provided, framed to address your questions where possible, and highlighting what is not present:
Device: Audit™ MicroCV™ hs-CRP Linearity Set
Intended Use (from the document):
"The Audit™ MicroCV™ hs-CRP Linearity Set is assayed quality control material consisting of five levels human based serum. Each level contains High Sensitivity C-Reactive Protein (hs -CRP) analyte. The five levels demonstrate a linear relationship to each other for High Sensitivity C-Reactive Protein (hs -CRP) analyte. It is intended to simulate human patient serum samples for purpose of monitoring and detecting systematic analytical deviations of laboratory testing procedures for High Sensitivity C-Reactive Protein (hs -CRP). This product may be used as quality control material for High Sensitivity C-Reactive Protein (hs -CRP) analyte. When used for quality control purposes, it is recommended that each laboratory establish its own means and acceptable ranges and use the values provided only as guides. The product is intended for use with quantitative assays on the indicated analyzer provided in the labeling. The Audit™ MicroCV™ hs-CRP Linearity Set is 'For In Vitro Diagnostic Use Only'."
1. Table of Acceptance Criteria and Reported Device Performance
For quality control materials like this, "acceptance criteria" usually relate to their stability (shelf life, open vial stability) and their ability to demonstrate a linear relationship. The document outlines these stability claims as performance.
| Characteristics | Acceptance Criteria (Implied / Claimed) | Reported Device Performance |
|---|---|---|
| Open Vial Stability | Expected to be stable for a specified duration when stored as instructed. | 10 days when stored tightly capped at 2-8°C. |
| Shelf Life | Expected to be stable for a specified duration when stored as instructed. | Two years at 2-8°C. |
| Linearity | The five levels are expected to demonstrate a linear relationship to each other for hs-CRP analyte, as they are related by linear dilution. | "The five levels demonstrate a linear relationship to each other for hs-CRP analyte." (This is stated in the intended use, implying they meet this design goal.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a "sample size" in terms of how many units of the linearity set were tested for stability or linearity demonstration. It refers to "five level set of QC material" and "five levels human based serum" which implies testing was performed on these five levels per set. The number of individual sets or batches tested is not stated.
- Data Provenance: Not explicitly stated, but the studies were "performed to determine the shelf life" and all supporting data "is retained on file at Aalto Scientific, Ltd." This suggests internal, retrospective testing conducted by the manufacturer (Aalto Scientific, Ltd., Carlsbad, CA). There is no mention of country of origin for the data or whether it was prospective/retrospective beyond the general phrasing for stability studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable to this type of device. The "Audit™ MicroCV™ hs-CRP Linearity Set" is a quality control material, not a diagnostic device that produces results requiring interpretation by experts against a ground truth. Its "ground truth" (or established values for each level) would be determined by precise analytical methods and certified reference materials, not expert consensus. The linearity is a characteristic of the set itself.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods (like 2+1, 3+1) are used in studies where human readers interpret diagnostic results (e.g., medical images) and their interpretations need to be reconciled to establish a consensus ground truth. This is not relevant for a quality control linearity set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC study was not done. This type of study is used to compare the diagnostic performance of different methods or human readers, often involving AI assistance, when interpreting patient cases. The device described here is a quality control material, not a diagnostic tool requiring such a study.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical quality control material used with analytical instruments, not an algorithm. Therefore, "standalone performance" in the context of an algorithm is irrelevant.
7. The Type of Ground Truth Used
For stability studies, the "ground truth" would be the initial, accurately measured concentration of hs-CRP in each level of the material. Subsequent measurements over time are compared to these initial values to determine if the material remains within acceptable analytical variation. For linearity, the "ground truth" is that the levels B, C, D are derived by linear dilution of levels A and E, so the expectation is a proportional relationship in measured values.
The document implicitly refers to:
- Analytically determined values: The hs-CRP concentrations are established through quantitative assays.
- Designed characteristics: The linear relationship between levels A-E is a design feature ("Levels B – D are related by linear dilution of Level A and Level E").
There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for this product.
8. The Sample Size for the Training Set
This is not applicable. The device is a quality control material, not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established
This is not applicable, as there is no training set for this product.
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510(k) Summary
A. Submitter
DEC 2 3 2010
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
Desember 23, 2010
D. Device Identification
Product Trade Name: Common Name: Classification Name: Device Classification: Regulation Number: Panel: Product Code:
Audit™ MicroCVTM hs-CRP Linearity Set hs-CRP Linearity Assay QC Material Class I 21 CFR 862.1660 7 ર JJX
E. Device to Which Substantial Equivalence is Claimed
Audit™ MicroCVTM General Chemistry Linearity Set Aalto Scientific, Ltd., Carlsbad, CA K042318
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Image /page/1/Picture/0 description: The image shows a logo for Aalto Scientific, Ltd. The logo consists of a triangular shape made up of many small dots. Below the triangle, the text "Aalto Scientific, Ltd." is written in a simple, sans-serif font. The text is left-aligned and appears to be slightly blurred.
F. Description of the Device
The Audit™ MicroCVTM hs-CRP Linearity Set is a human based, liquid, five level set of QC material, with each level containing one analyte: High Sensitivity C-Reactive Protein (hs -CRP). It is used to confirm the proper calibration, linear operating range, and reportable range of hs-CRP. 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™ MicroCVTM hs-CRP Linearity Set is assayed quality control material consisting of five levels human based serum. Each level contains High Sensitivity C-Reactive Protein (hs -CRP) analyte. The five levels demonstrate a linear relationship to each other for High Sensitivity C-Reactive Protein (hs -CRP) analyte. It is intended to simulate human patient serum samples for purpose of monitoring and detecting systematic analytical deviations of laboratory testing procedures for High Sensitivity C-Reactive Protein (hs -CRP). This product may be used as quality control material for High Sensitivity C-Reactive Protein (hs -CRP) analyte. When used for quality control purposes, it is recommended that each laboratory establish its own means and acceptable ranges and use the values provided only as guides. The product is intended for use with quantitative assays on the indicated analyzer provided in the labeling. The Audit™ MicroCV™ hs-CRP Linearity Set is "For In Vitro Diagnostic Use Only".
I. Summary of Performance Data
Stability studies have been performed to determine the shelf life for the Audit™ MicroCV™ hs-CRP 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, High Sensitivity C-Reactive Protein (hs -CRP) will be stable for 10 days when stored tightly capped at 2-8 C.
Shelf Life: Two years at 2 - 8º C.
Note: Real time studies are ongoing to support the shelf life of this product.
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Image /page/2/Picture/0 description: The image shows the logo for Aalto Scientific, Ltd. The logo consists of a triangle shape made up of smaller triangles, with the company name written below it. The text "Aalto Scientific, Ltd." is in a simple, sans-serif font. The year 2018 is also present in the image.
| Characteristics | Audit™ MicroCVTM hS-CRPLinearity Set(K101427) | Audit™ MicroCVTM General ChemistryLinearity Set(K042318) |
|---|---|---|
| Intended Use | The Audit™ MicroCVTM hs-CRP LinearitySet is assayed quality control materialconsisting of five levels human based serum.Each level contains High Sensitivity C-Reactive Protein (hs -CRP) analyte. The fivelevels demonstrate a linear relationship toeach other for High Sensitivity C-ReactiveProtein (hs -CRP) analyte. It is intended tosimulate human patient serum samples forpurpose of monitoring and detectingsystematic analytical deviations of laboratorytesting procedures for High Sensitivity C-Reactive Protein (hs -CRP). This productmay be used as quality control material forHigh Sensitivity C-Reactive Protein (hs -CRP) analyte. When used for quality controlpurposes, it is recommended that eachlaboratory establish its own means andacceptable ranges and use the valuesprovided only as guides. The product isintended for use with quantitative assays onthe indicated analyzer provided in thelabeling,The Audit™ MicroCV™ hs-CRPLinearity Set is "For In Vitro Diagnostic UseOnly". | Audit™ MicroCVTM General ChemistryLinearity Set is assayed quality controlmaterial consisting of human based serum. Itis intended to simulate human patient serumsamples for the purpose of monitoring theprecision and to detect systematic analyticaldeviations of laboratory testing procedures.This product 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 2 mL | 5 x 5 mL |
| Matrix | Human Based Serum | Human Based Serum |
| Type of Analytes | Clinical Chemistry | General Chemistry |
| 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 Vial Stability | 10 days at 2-8 °C | 7 days at 2 to 8° C except for enzymes andbilirubin |
H. Technical Characteristics Compared to Predicate Device
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Image /page/3/Picture/0 description: The image shows a logo for Aalto Scientific, Ltd. The logo consists of a triangle shape made up of many smaller circles or dots. Below the triangle, the text "Aalto Scientific, Ltd." is written in a stylized font. The text "Andro" is also present, but it is unclear if it is part of the logo or separate text.
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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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: K101427
Trade Name: Audit™ MicroCV™ HS-CRP 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.
C.C.
Courmey 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 (if known): K101427
DEC 2 3 2010
Device Name: Audit™ MicroCV™ hs -CRP Linearity Set
Indications For Use:
The Audit™ MicroCV™ hs-CRP Linearity Set is assayed quality control material consisting of five levels human based serum. Each level contains High Sensitivity C-Reactive Protein (hs -CRP) analyte. The five levels demonstrate a linear relationship to each other for High Sensitivity C-Reactive Protein (hs -CRP) analyte. It is intended to simulate human patient serum samples for purpose of monitoring and detecting systematic analytical deviations of laboratory testing procedures for High Sensitivity C-Reactive Protein (hs -CRP). This product may be used as quality control material for High Sensitivity C-Reactive Protein (hs -CRP) analyte. When used for quality control purposes, it is recommended that each laboratory establish its own means and acceptable ranges and use the values provided only as guides. The product is intended for use with quantitative assays on the indicated analyzer provided in the labeling. The Audit™ MicroCVTM hs-CRP 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 C Benson
ion Sign-Off
Cice of In Vitro Diagnostic Device Branstion 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.