(184 days)
Not Found
No
The device description and intended use focus on a linearity set for quality control and calibration verification of laboratory assays. There is no mention of AI or ML in the provided text.
No
This device is an "In Vitro Diagnostic Use Only" product, specifically a linearity set and quality control material for laboratory use with automatic analyzers, not for direct patient treatment.
No
The device is a linearity set and quality control material used to confirm the proper calibration and operating range of diagnostic assays, rather than directly diagnosing disease in a patient. It is specifically stated as "For In Vitro Diagnostic Use Only," which implies it supports diagnostic procedures but is not itself a diagnostic device.
No
The device is a linearity set consisting of physical solutions (human and bovine albumin based matrix) used for calibrating and controlling laboratory instruments. It is not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The Audit™ Free T4 / Free T3 Linearity Set is 'For In Vitro Diagnostic Use Only'".
- Intended Use: The device is intended for use with quantitative assays on automatic analyzers to confirm proper calibration, linear operating range, and reportable range of Free T4 / Free T3 analytes. This is a diagnostic purpose performed in vitro (outside the body).
- Quality Control: It is also indicated for use as a quality control material, which is a common application for IVD devices to ensure the accuracy and reliability of diagnostic tests.
N/A
Intended Use / Indications for Use
The Audit™ MicroCV™ Free T4 / Free T3 Linearity Set consists of five levels of human and bovine albumin based matrix. Each level contains the following analytes: Free T4 and Free T3. The five levels demonstrate a linear relationship to each other for their respective analytes, reagents, and instruments.
This product may also be used as a quality control material for these analytes. 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 automatic analyzers. The Audit™ Free T4 / Free T3 Linearity Set is "For In Vitro Diagnostic Use Only".
Product codes (comma separated list FDA assigned to the subject device)
JJY
Device Description
The Audit™ MicroCV™ Free T4 / Free T3 Linearity Set is a 5 level quality control solution set containing Free T4 / Free T3 analytes as the messurand. It is used to confirm the proper calibration, linear operating range, and reportable range of Free T4 / Free T3 analytes. 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.
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
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Stability studies have been performed to determine the open vial stability and shelf life for the Audit™ MicroCV™ Free T4 / Free T3 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 5 days when stored tightly capped at 2-8 C.
Shelf Life: 24 months 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.)
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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.
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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.
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1103601
JUN 1 0 2011
510(k) Summary
A. Submitter
Aalto Scientific, Ltd. 1959 Kellogg Ave. Carlsbad, CA 92008 Telephone: 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
June 7, 2011
D. Device Identification
| Product Trade Name: | Audit™ MicroCV™ Free T4 / Free T3 Linearity Set |
|---|---|
| Common Name: | Calibration Verification |
| Classification Name: | Multi analyte controls (Assayed and Unassayed) |
| Device Classification: | Class I |
| Regulation Number: | 21 CFR 862.1660 |
| Panel: | 75 |
| Product Code: | JJY |
E. Legally marketed (unmodified) device
Product Trade Name:
Audit MicroCV Free T4 / Free T3 Linearity Set Aalto Scientific, Ltd., Carlsbad, California K062668
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F. Description of the Modified Device
The Audit™ MicroCV™ Free T4 / Free T3 Linearity Set is a 5 level quality control solution set containing Free T4 / Free T3 analytes as the messurand. It is used to confirm the proper calibration, linear operating range, and reportable range of Free T4 / Free T3 analytes. 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.
Statement of Intended Use
The Audit™ MicroCV™ Free T4 / Free T3 Linearity Set consists of five levels of human and bovine albumin based matrix. Each level contains the following analytes: Free T4 and Free T3. The five levels demonstrate a linear relationship to each other for their respective analytes, reagents, and instruments.
This product may also be used as a quality control material for these analytes. 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 automatic analyzers. The Audit™ Free T4 / Free T3 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™ MicroCV™ Free T4 / Free T3 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 5 days when stored tightly capped at 2-8 C.
Shelf Life: 24 months 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 Unmodified Device
.
| Characteristics | Audit™ MicroCV™
Free T4 / Free T3 Linearity Set
K103601 | Audit™ MicroCV™
Immunoassay Linearity Set
K062668 |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Audit™ MicroCV™ Free T4 / Free
T3 Linearity Set consists of five levels
of human and bovine albumin based
matrix. Each level contains the
following analytes: Free T4 and Free
T3. The five levels demonstrate a
linear relationship to each other for
their respective analytes, reagents,
and instruments.
This product may also be used as a
quality control material for these
analytes. 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 automatic
analyzers. The Audit™ Free T4 / Free
T3 Linearity Set is "For In Vitro
Diagnostic Use Only". | Audit™ MicroCV™ Immunoassay
Linearity Set is assayed quality control
material consisting of human Albumin
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 and
may be used for proficiency testing in
interlaboratory surveys. In addition,
this product may also be used to
perform CLIA directed calibration
verification for these same analytes
with similar reagents on similar
instrumentation in accordance with
current CLIA-88 guidelines and
regulations. |
| Number of levels per set | 5 | 5 |
| Contents | 5 x 5mL | 5 x 5mL |
| Matrix | Human and Bovine Albumin Serum | Human and Bovine Albumin Serum |
| Type of Analytes | Free T4 and Free T3 | Cortisol, Digoxin, Estradiol, Ferritin,
Folate, Free T4, FSH, hCG, LH,
Progesterone, Prolactin, Testosterone,
Total PSA, Total T3, Total T4, TSH,
and Vitamin B12. |
| Form | Lyophilized | Lyophilized |
| Storage | 2 to 8º C for 24 months | 2 to 8º C for 24 months |
| Open Bottle Stability | 5 days at 2 to 8° C | 5 days at 2 to 8° C |
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J. Conclusions
Based upon the purpose of the device, the descriptions and labeling of the unmodified device, the safety and efficacy, the risk analyses, and the stability data generated, the modified product is practically identical to the unmodified device.
4
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Aalto Scientific Ltd. c/o Dessi Lyakov, Regulatory Affairs Manager 1959 Kellogg Ave. Carlsbad. CA 92008
JUN 1 0 2011
Re: K103601
Trade/Device Name: Audit™ MicroCV™ FreeT4/FreeT3 Linearity Set Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (Assayed and Unassayed) Regulatory Class: Class I. reserved Product Code: JJY Dated: 24 March, 2011 Received: 29 March, 2011
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 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). This letter will allow you to begin marketing your device as described in your Section 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.
Image /page/4/Picture/11 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
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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.
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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Image /page/6/Picture/0 description: The image shows a logo for a company called "Aullo Scientific, Ltd.". The logo consists of a triangle shape made up of many small dots. The company name is written in a stylized font below the triangle.
Indications for Use
510(k) Number: K103601
Device Name: Audit™ MicroCV Free T4 / Free T3 Linearity Set
Indications For Use:
The Audit™ MicroCV™ Free T4 / Free T3 Linearity Set consists of five levels of human and bovine albumin based matrix. Each level contains the following analytes: Free T4 and Free T3. The five levels demonstrate a linear relationship to each other for their respective analytes, reagents, and instruments.
This product may also be used as a quality control material for these analytes. 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 automatic analyzers. The Audit™ Free T4 / Free T3 Linearity Set is "For In Vitro Diagnostic Use Only".
Prescription Use × (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. Benam
Division Sign-Off Office of In Vitro Diagnostic Devices Evaluation and Safety
510(k) K103601
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