(55 days)
Not Found
No
The device is a quality control material for laboratory assays and does not involve any computational analysis or algorithms.
No.
The device is an in vitro diagnostic quality control material used to verify the linearity and reportable range of Beta-Hydroxybutyric Acid assays, not to treat or diagnose patients.
No
This device is described as an "assayed quality control material" used for determining linearity, calibration verification, and verification of reportable range for Beta-Hydroxybutyric Acid assays. It simulates patient samples but is not used to diagnose or treat any condition; rather, it ensures the proper functioning of diagnostic equipment.
No
The device is a physical quality control material consisting of human-based serum, 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® MicroCV™ Beta- Hydroxybutyric Acid Linearity Set is 'For In Vitro Diagnostic Use Only'".
- Intended Use: The intended use is to simulate human patient serum samples for the purpose of determining linearity, calibration verification, and verification of reportable range for Beta-Hydroxybutyric Acid on quantitative assays. This is a classic function of an in vitro diagnostic control material.
- Device Description: The device is described as an assayed quality control material consisting of human-based serum, used to confirm calibration, linear operating range, and reportable range of an analyte. This aligns with the definition of an IVD control.
- Care Setting: It is intended for use in a laboratory setting with quantitative assays, which is where IVD testing is performed.
N/A
Intended Use / Indications for Use
The Audit® MicroCV™ Beta-Hydroxybutyric Acid Linearity Set is an assayed quality control material consisting of five levels of human based serum. Each level contains Beta- Hydroxybutyric Acid. These five levels demonstrate a linear relationship to each other for Beta-Hydroxybutyric Acid. It is intended to simulate human patient serum samples for purpose of determining linearity, calibration verification and verification of reportable range for Beta- Hydroxybutyric Acid.
The product is intended for use with quantitative assays on the indicated analyzer provided in the labeling and may be used as quality control material for Beta-Hydroxybutyric Acid. 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 Audit® MicroCV™ Beta- Hydroxybutyric Acid Linearity Set should not be used for calibration or standardization of the Beta- Hydroxybutyric Acid assay. The Audit® MicroCV™ Beta- Hydroxybutyric Acid Linearity Set is "For In Vitro Diagnostic Use Only".
Product codes
JJX
Device Description
The Audit® MicroCV™ Beta-Hydroxybutyric Acid Linearity Set is an assayed quality control material consisting of five levels of human based serum, with each level containing Beta-Hydroxybutyric Acid. It is used to confirm the proper calibration, linear operating range, and reportable range of Beta-Hydroxybutyric Acid. 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
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 open vial stability and shelf life for the Audit® MicroCV™ Beta-Hydroxybutyric Acid 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, the Beta-Hydroxybutyric Acid will be stable for 40 days when stored tightly capped at 2 - 8º C.
Shelf Life: Two years, when stored unopened at 2 - 8º C. Note: Real time studies are ongoing to support the shelf life of this product.
Value assignment of Audit® MicroCV™ Beta-Hydroxybutyric Acid Linearity Set have been performed to determine the expected values of Beta-Hydroxybutyric Acid analyte. All supporting data is retained on file at Aalto Scientific, Ltd. Product claims are as follows:
Beta-Hydroxybutyric Acid, mmol/L, P-Modular Instrument, Roche Reagent
Level A: Target value 0.0, Target Range 0.0
Level B: Target value 1.2, Target Range 1.0-1.4
Level C: Target value 2.3, Target Range 2.0-2.6
Level D: Target value 3.4, Target Range 2.9-3.9
Level E: Target value 4.4, Target Range 3.8-5.1
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.
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Image /page/0/Picture/1 description: The image shows a logo for a company called "Aalto Scientific, Ltd." The logo consists of a triangular shape made up of many small dots, resembling a mountain or a pyramid. Below the triangular shape, the company name is written in a stylized font.
MAR 1 9 2013 510(k) Notification Audit® MicroCV™ Beta-Hydroxybutyric Acid Linearity Set
510(k) Summarv
A. Submitter
Aalto Scientific, Ltd. 1959 Kellogg Ave. Carlsbad, CA 92008 Telephone: (760) 431-7922 Fax: (760) 431-6824
B. Contact Person
Dessi Lyakov Regulatory Affairs Manager Telephone: (760) 431-7922 Ext. 118 E-mail: dlyakov@aaltoscientific.com
C. Date of Summary Preparation
February 15, 2013
D. Device Identification
| Product Trade Name: | Audit® MicroCVTM Beta-Hydroxybutyric Acid Linearity Se |
|---|---|
| Common Name: | Beta-Hydroxybutyric Acid Linearity |
| Classification Name: | Assay QC Material |
| Device Classification: | Class I, reserved |
| Regulation Number: | 21 CFR 862.1660 |
| Panel: | 75 |
| Product Code: | JJX |
| Device to Which Substantial Equivalence is Claimed | |
| Product Trade Name: | Audit® MicroCVTM hs-CRP Linearity Set |
| Aalto Scientific, Ltd., Carlsbad, CA | |
| K101427 |
E. Description of the Device
The Audit® MicroCV™ Beta-Hydroxybutyric Acid Linearity Set is an assayed quality control material consisting of five levels of human based serum, with each level containing Beta-Hydroxybutyric Acid. It is used to confirm the proper calibration, linear operating range, and reportable range of Beta-Hydroxybutyric Acid. 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.
F. Statement of Intended Use
The Audit® MicroCV™ Beta-Hydroxybutyric Acid Linearity Set is an assayed quality control material consisting of five levels of human based serum. Each level contains Beta-Hydroxybutyric Acid. These five levels demonstrate a linear relationship to each other for
Page 3 of 23
1
510(k) Notification Audit® MicroCV™ Beta-Hydroxybutyric Acid Linearity Set
Beta-Hydroxybutyric Acid. It is intended to simulate human patient serum samples for purpose of determining linearity, calibration verification and verification of reportable range for Beta-Hydroxybutvric Acid,
The product is intended for use with quantitative assays on the indicated analyzer provided in the labeling and may be used as quality control material for Beta-Hydroxybutyric Acid. 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 Audit® MicroCV™ Beta-Hydroxybutyric Acid Linearity Set should not be used for calibration or standardization of the Beta-Hydroxybutyric Acid assay. The Audit® MicroCV™ Beta-Hydroxybutyric Acid Linearity Set is "For In Vitro Diagnostic Use Only".
G. Summary of Performance Data
Stability studies have been performed to determine the open vial stability and shelf life for the Audit® MicroCV™ Beta-Hydroxybutyric Acid 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, the Beta-Hydroxybutyric Acid will be stable for 40 days when stored tightly capped at 2 - 8º C.
Shelf Life: Two years, when stored unopened at 2 - 8º C. Note: Real time studies are ongoing to support the shelf life of this product.
H. Expected Values
Value assignment of Audit® MicroCV™ Beta-Hydroxybutyric Acid Linearity Set have been performed to determine the expected values of Beta-Hydroxybutyric Acid analyte. All supporting data is retained on file at Aalto Scientific, Ltd. Product claims are as follows:
| Beta-Hydroxybutyric Acid, mmol/L, P-Modular Instrument, Roche Reagent | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Level A | Level B | Level C | Level D | Level E | |||||
| Target value | Target Range | Target value | Target Range | Target value | Target Range | Target value | Target Range | Target value | Target Range |
| 0.0 | 0.0 | 1.2 | 1.0-1.4 | 2.3 | 2.0-2.6 | 3.4 | 2.9-3.9 | 4.4 | 3.8-5.1 |
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Image /page/2/Picture/0 description: The image shows a logo with a triangular shape at the top, which appears to be made up of many small dots or pixels. Below the logo, there is text that reads "Aalto Scientific, Ltd." The text is in a simple, sans-serif font and is left-aligned. The overall image has a slightly grainy or low-resolution quality.
510(k) Notification Audit® MicroCV™ Beta-Hydroxybutyric Acid Linearity Set
| Characteristics | Audit® MicroCV™ Beta-Hydroxybutyric Acid
Linearity Set
(New) | Audit™ MicroCV™ hs-CRP
Linearity Set
(K101427) |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Audit® MicroCV™ Beta-Hydroxybutyric Acid
Linearity Set is an assayed quality control material
consisting of five levels of human based serum.
Each level contains Beta-Hydroxybutyric Acid.
These five levels demonstrate a linear relationship
to each other for Beta-Hydroxybutyric Acid. It is
intended to simulate human patient serum
samples for purpose of determining linearity,
calibration verification and verification of
reportable range for Beta-Hydroxybutyric Acid.
The product is intended for use with quantitative
assays on the indicated analyzer provided in the
labeling and may be used as quality control
material for Beta-Hydroxybutyric Acid. 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 Audit® MicroCV™ Beta-
Hydroxybutyric Acid Linearity Set should not be
used for calibration or standardization of the Beta-
Hydroxybutyric Acid assay. The Audit® MicroCV™
Beta-Hydroxybutyric Acid Linearity Set is "For In
Vitro Diagnostic Use Only". | 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". |
| Number of
Analytes per vial | 1 | 1 |
| Number of
levels per set | 5 | 5 |
| Contents | 5 x 1 mL | 5 x 1 mL |
| Matrix | Human Based Serum | Human Based Serum |
| Type of Analytes | Beta-Hydroxybutyric Acid | High Sensitivity C-Reactive Protein |
| Form | Liquid | Liquid |
| Storage | 2 to 8 ° C
Until expiration date | 2 to 8 ° C
Until expiration date |
| Open Vial
Stability | 40 days at 2 to 8 ° C | 20 days at 2 to 8 ° C |
I. Technical Characteristics Compared to Predicate Device
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.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the HHS logo, which is a stylized representation of a human figure embracing the world. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged around the logo in a circular fashion.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 19, 2013
Aalto Scientific, Ltd c/o Dessi Lyakov 1959 Kellogg Ave. Carlsbad, CA 92008
Re: K130157
Trade/Device Name: Audit ® MicroCV™ Beta-Hydroxybutyric Acid Linearity Set Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material Regulatory Class: Class I, reserved Product Code: JJX Dated: January 14, 2013 Received: February 06, 2013
Dear Dessi 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 Part 801); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for
4
Page 2- Dessi Lyakov
the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Carol C. Benson -S for
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number: K130157
Device Name: Audit® MicroCV™ Beta-Hydroxybutyric Acid Linearity Set
Indications for Use:
The Audit® MicroCV™ Beta-Hydroxybutyric Acid Linearity Set is an assayed quality control material consisting of five levels of human based serum. Each level contains Beta- Hydroxybutyric Acid. These five levels demonstrate a linear relationship to each other for Beta-Hydroxybutyric Acid. It is intended to simulate human patient serum samples for purpose of determining linearity, calibration verification and verification of reportable range for Beta- Hydroxybutyric Acid.
The product is intended for use with quantitative assays on the indicated analyzer provided in the labeling and may be used as quality control material for Beta-Hydroxybutyric Acid. 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 Audit® MicroCV™ Beta-Hydroxybutyric Acid Linearity Set should not be used for calibration or standardization of the Beta-Hydroxybutyric Acid assay. The Audit® MicroCV™ Beta- Hydroxybutyric Acid Linearity Set is "For In Vitro Diagnostic Use Only".
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Yung WOChan-S
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k) K130157