(216 days)
Not Found
No
The device is a quality control material used to verify the linearity of laboratory tests for hs-CRP. It does not involve any computational analysis or algorithms that would suggest AI/ML.
No.
This device is an in vitro diagnostic quality control material used to monitor and detect systematic analytical deviations of laboratory testing procedures, not to treat or directly manage patient health.
No
This device is described as quality control material used to monitor and detect systematic analytical deviations of laboratory testing procedures for C-Reactive Protein (hs-CRP), confirm calibration, and establish linear operating ranges. It simulates human patient samples but does not directly diagnose a patient's condition.
No
The device is a physical quality control material (human based serum) and not a software application.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states 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 clearly indicates it is used in vitro (outside the body) to evaluate the performance of diagnostic tests.
- "For In Vitro Diagnostic Use Only": The labeling explicitly states "The Audit™ MicroCVTM hs-CRP Linearity Set is 'For In Vitro Diagnostic Use Only'". This is a definitive statement that the device is intended for IVD purposes.
- Quality Control Material: The device is described as "quality control material" and is used to "confirm the proper calibration, linear operating range, and reportable range of hs-CRP." Quality control materials are a type of IVD used to ensure the accuracy and reliability of diagnostic tests.
- Used with Quantitative Assays: The product is intended for use with "quantitative assays on the indicated analyzer provided in the labeling." This further confirms its role in the diagnostic testing process.
- Predicate Device: The predicate device listed (K042318; Audit™ MicroCVTM General Chemistry Linearity Set) is also a linearity set used for quality control in general chemistry testing, which falls under the umbrella of IVDs.
All of these points strongly indicate that the Audit™ MicroCV™ hs-CRP Linearity Set is an In Vitro Diagnostic device.
N/A
Intended Use / 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".
Product codes (comma separated list FDA assigned to the subject device)
JJX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows a logo for Aalto Scientific, Ltd. The logo consists of a triangle shape at the top, which appears to be made up of smaller dots or pixels. Below the triangle, the text "Aalto Scientific, Ltd" is written in a serif font. The text is slightly blurred, suggesting that the image may be a scan or a low-resolution version of the original logo.
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
1
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.
2
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-CRP
Linearity Set
(K101427) | Audit™ MicroCVTM General Chemistry
Linearity Set
(K042318) |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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". | Audit™ MicroCVTM General Chemistry
Linearity Set is assayed quality control
material consisting of human based serum. 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.
This product may also be used as unassayed
quality control material for these same
analytes. |
| Number of
Analytes per vial | 1 | 30 |
| Number of levels
per 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 | Sorbitol
Sodium azide |
| Storage | 2 to 8° C
Until expiration date | 2 to 8° C
Until expiration date |
| Open Vial Stability | 10 days at 2-8 °C | 7 days at 2 to 8° C except for enzymes and
bilirubin |
H. Technical Characteristics Compared to Predicate Device
3
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.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a circular text element on the left and a stylized graphic on the right. The text element contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion. The graphic on the right depicts a stylized eagle or bird-like figure with outstretched wings.
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).
5
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.
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
6
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