(66 days)
Not Found
No
The summary describes a quality control material for laboratory testing, not a device that processes data or images using AI/ML. There are no mentions of AI, ML, or related concepts.
No.
The device is described as quality control material intended to monitor the precision and detect systematic analytical deviations of laboratory testing procedures, not to treat or diagnose a disease.
No
This device is a quality control material intended to monitor the precision and detect analytical deviations of laboratory testing procedures, not to diagnose a patient's condition.
No
The device is a physical quality control material (human based serum) and not a software application.
Based on the provided information, 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 the precision and to detect systematic analytical deviations of laboratory testing procedures for Anti-streptolysin O (ASO)." This clearly indicates it is used in vitro (outside the body) to evaluate the performance of diagnostic tests.
- Device Description: It is described as "human based, liquid, five level set of QC material," which is a common format for IVD quality control materials.
- Intended User / Care Setting: It is intended for "laboratory testing procedures," which is the typical setting for IVD use.
- Predicate Device: The mention of a predicate device (K042318; Audit™ MicroCV™ General Chemistry Linearity Set) further supports its classification as an IVD, as predicate devices are used for comparison in regulatory submissions for new IVDs.
The device is a quality control material used to ensure the accuracy and reliability of laboratory tests for Anti-streptolysin O (ASO), which is a diagnostic analyte. This function falls squarely within the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Audit™ MicroCVTM ASO Linearity Set is assayed quality control material consisting of five levels human based serum. Each level contains Anti-streptolysin O (ASO) analyte. The five levels demonstrate a linear relationship to each other for Anti-streptolysin O (ASO) analyte. It is intended to simulate human patient serum samples for purpose of monitoring the precision and to detect systematic analytical deviations of laboratory testing procedures for Anti-streptolysin O (ASO). This product may be used as unassayed quality control material for Anti-streptolysin O (ASO) analyte.
Product codes
MJX
Device Description
The Audit™ MicroCV™ ASO Linearity Set is a human based, liquid, five level set of QC material, with each level containing one analyte: Anti-streptolysin O (ASO). It is used to confirm the proper calibration, linear operating range, and reportable range of ASO. 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™ ASO 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, all analytes will be stable for 24 hours when stored tightly capped at 2-8 C.
Shelf Life: Two years at 2 - 8° 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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
KC00752
Image /page/0/Picture/1 description: The image shows a logo for Aalto Scientific, Ltd. The logo features a triangular shape made up of small dots, resembling a mountain or pyramid. Below the shape, the text "Aalto Scientific, Ltd" is printed in a simple, sans-serif font.
510(k) Summary
A. Submitter
Aalto Scientific, Ltd. 1959 Kellogg Ave. Carlsbad, CA 92008 Telephone: (760) 431-7922 (760) 431-6824 Fax:
MAY 2 4 2010
B. Contact Person
Dessi Lyakov Telephone: (760) 431-7922 Ext. 118 E-mail: dlyakov@aaltoscientific.com
C. Date of Summary Preparation
・レ
March 12, 2010
D. Device Identification
Product Trade Name: Common Name: Classification Name: Device Classification: Regulation Number: Panel: Product Code:
Audit™ MicroCVTM ASO Linearity Set ASO Linearity Assay QC Material Class I 21 CFR 862.1660 83 MJX
E. Device to Which Substantial Equivalence is Claimed
Audit™ MicroCV™ Gencral Chemistry Lincarity Sct 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 triangle made up of many small dots, with the company name printed below it. The text is in a small, sans-serif font and is left-aligned.
F. Description of the Device
The Audit™ MicroCV™ ASO Linearity Set is a human based, liquid, five level set of QC material, with each level containing one analyte: Anti-streptolysin O (ASO). It is used to confirm the proper calibration, linear operating range, and reportable range of ASO. 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™ ASO Linearity Set is assayed quality control material consisting of five levels human based serum. Each level contains Anti-streptolysin O (ASO) analyte. The five levels demonstrate a linear relationship to each other for Antistreptolysin O (ASO) analyte. It is intended to simulate human patient serum samples for purpose of monitoring the precision and to detect systematic analytical deviations of laboratory testing procedures for Anti-streptolysin O (ASO). This product may be used as an unassayed quality control material for Anti-streptolysin O (ASO) analyte.
I. Summary of Performance Data
Stability studies have been performed to determine the shelf life for the Audit™ MicroCV™ ASO 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, all analytes will be stable for 24 hours when stored tightly capped at 2-8 C.
Shelf Life: Two years at 2 - 8° 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 a logo with a triangular shape at the top, resembling a mountain or a pyramid, composed of many small dots. Below the triangular shape, there is text that reads "Anto Scientille, Ltd". The text is in a smaller font size compared to the triangular shape, and it appears to be the name or branding associated with the logo.
H. Technical Characteristics Compared to Predicate Device
| Characteristics | Audit™ MicroCV™ ASO Linearity Set
(New Device) | Audit™ MicroCV™ General Chemistry
Linearity Set
(K042318) |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Audit™ MicroCV™ ASO Linearity
Set is assayed quality control material
consisting of five levels human based
serum. Each level contains Anti-
streptolysin O (ASO) analyte. The five
levels demonstrate a linear relationship
to each other for Anti-streptolysin O
(ASO) analyte. It is intended to simulate
human patient serum samples for
purpose of monitoring the precision and
to detect systematic analytical deviations
of laboratory testing procedures for Anti-
streptolysin O (ASO). This product may
also be used as unassayed quality control
material for Anti-streptolysin O (ASO)
analyte. | Audit™ MicroCV™ 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 1 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 | Sorbitol
Sucrose
Sodium azide | Sorbitol
Sodium azide |
| Storage | 2 to 8° C
Until expiration date | 2 to 8° C
Until expiration date |
| Open Vial
Stability | 24 hours at 2-8 C | 7 days at 2 to 8° C except for enzymes
and bilirubin which are 48 hours |
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 small circles. Below the triangle is the text "Aalto Scientific, Ltd."
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 seal of the Department of Health & Human Services (USA). The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Aalto Scientific, Ltd. c/o Dessi Lyakov Manager, Regulatory Affairs 1959 Kellogg Ave. Carlsbad, California 92008
MAY 2 1 2010
| Re: | K100750 |
|---|---|
| Trade/Device Name: | Audit™ Micro CV™ ASO Linearity Set |
| Regulation Number: | 21CFR §862.1660 |
| Regulation Name: | Quality Control Material (assayed and unassayed) |
| Regulatory Class: | Class I |
| Product Code: | MJX |
| Dated: | March 12, 2010 |
| Received: | March 16, 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 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 (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
5
Page 2 - Dessi Lvakov
510(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 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,
Sallaams
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
6
Indications for Use
510(k) Number (if known): K100750
Device Name: Audit™ MicroCVTM ASO Linearity Set
Indications For Use:
The Audit™ MicroCVTM ASO Linearity Set is assayed quality control material consisting of five levels human based serum. Each level contains Anti-streptolysin O (ASO) analyte. The five levels demonstrate a linear relationship to each other for Anti-streptolysin O (ASO) analyte. It is intended to simulate human patient serum samples for purpose of monitoring the precision and to detect systematic analytical deviations of laboratory testing procedures for Anti-streptolysin O (ASO). This product may be used as unassayed quality control material for Anti-streptolysin O (ASO) 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)
Luddie Lu. Poole
on Sign
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k).