(62 days)
Not Found
No
The device is a quality control material for laboratory testing and does not involve any computational analysis or algorithms.
No
This device is a quality control material intended to monitor the precision and detect analytical deviations of laboratory testing procedures, not to treat or diagnose patients.
No
Explanation: This device is a quality control material used for monitoring the precision and detecting analytical deviations in laboratory testing procedures for a specific analyte (Procalcitonin). It is not directly used to diagnose a patient's condition.
No
The device is a physical quality control material (freeze-dried bovine serum albumin with Procalcitonin) used in laboratory testing, not a software application.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that 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 clearly indicates its use in the in vitro examination of specimens derived from the human body.
- Device Description: The description further clarifies its use in confirming "the proper calibration, linear operating range, and reportable range of Procalcitonin," which are all activities performed in a laboratory setting on patient samples.
- Intended User/Care Setting: The intended user is "laboratory testing procedures," reinforcing its use in a clinical laboratory environment.
While it is a quality control material and not a diagnostic test itself, it is an essential component used with diagnostic tests performed in vitro on human specimens. Therefore, it falls under the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
83 MJX
Device Description
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.
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™ 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.
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.
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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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Image /page/1/Picture/0 description: The image shows a logo for Aalto Scientific, Ltd. The logo features a triangular shape at the top, which appears to be composed of many small dots or pixels. Below the triangular shape, the text "Aalto Scientific, Ltd." is written in a simple, sans-serif font. The text is aligned horizontally and centered below the triangular shape.
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.
2
Image /page/2/Picture/0 description: The image shows a logo for a company called "Adu) Scientific, Ltd.". The logo consists of a triangle shape made up of many small dots. There are some abstract shapes inside the triangle. The text "Adu) Scientific, Ltd." is written in a small, sans-serif font below the triangle.
H. Technical Characteristics Compared to Predicate Device
| Characteristics | Audit™ MicroCV™ Procalcitonin
Linearity Set
(New Device) | Audit™ MicroCV™ General Chemistry
Linearity Set
(K042318) |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | 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. | 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 | Bovine Serum Albumin | Human Based Serum |
| Type of Analytes | Clinical Chemistry | General Chemistry |
| Form | Lyophilized | 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 | 5 days at 2-8 C | 7 days at 2 to 8° C except for enzymes
and bilirubin |
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Image /page/3/Picture/0 description: The image shows a logo or emblem with a triangular shape at the top, filled with a dense pattern of dots or small circles, giving it a textured appearance. Below the triangular shape, there is some text that reads "Addo Scientific; 1 ht". The text is in a smaller font size compared to the overall size of the emblem.
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
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle 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
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