(63 days)
Not Found
No
The summary describes a linearity set for therapeutic drug monitoring, which is a chemical reference material used for calibration and quality control. There is no mention of any computational or algorithmic components, let alone AI/ML.
No.
The device is a linearity set and quality control material used for calibrating and verifying the performance of analyzers, not for directly treating patients.
No
This device is described as a linearity set and quality control material used to verify the calibration and linear operating range of therapeutic drug monitoring (TDM) methods. It does not directly diagnose a patient's condition.
No
The device is a physical product (lyophilized material in vials) used for calibration and quality control, not a software application.
Based on the provided information, the Audit™ MicroCV™ Therapeutic Drug (TDM) Linearity Set is an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use explicitly states that the product is used for "proficiency testing in interlaboratory surveys and to perform CLIA directed calibration verification for these same analytes with similar reagents on similar instrumentation". Calibration verification and proficiency testing are activities performed in a laboratory setting to ensure the accuracy and reliability of diagnostic tests.
- Device Description: The description states it is a "QC material" used to "confirm the proper calibration, linear operating range, and reportable range of Therapeutic Drug (TDM) methods". Quality control materials are essential components of IVD testing to monitor performance.
- Analytes: The product contains specific therapeutic drugs (Acetaminophen, Amikacin, Carbamazepine, etc.) which are analytes commonly measured in clinical laboratories for patient diagnosis and monitoring.
- Matrix: The matrix is "Human and Bovine serum albumin matrix", indicating it is designed to mimic biological samples.
- Regulatory Context: The mention of "CLIA-88 guidelines and regulations" further reinforces its use in a regulated clinical laboratory environment.
- Predicate Device: The predicate device listed (K042318; Audit™ MicroCV™ General Chemistry Linearity Set) is also a linearity set used for calibration verification, which is a common type of IVD accessory.
While the device itself doesn't directly diagnose a disease, it is an essential tool used in conjunction with IVD tests to ensure their accuracy and reliability. This function falls squarely within the definition of an IVD accessory or control material.
N/A
Intended Use / Indications for Use
The Therapeutic Drug (TDM) Linearity Set is intended to simulate human patient serum samples for the purpose of verifying and validating the Analytical Measurement Range for non-waived Therapeutic Drug (TDM) testing methods as identified in the package insert.
The Audit™ MicroCV™ Therapeutic Drug (TDM) Linearity Set consists of five levels in Human and Bovine serum albumin matrix. Each level contains the following analytes: Acetaminophen, Amikacin, Carbamazepine, Digoxin, Gentamicin, Methotrexate, Phenobarbital, Phenytoin, Quinidine, Salicylate, Theophylline, Tobramycin, Valoroic Acid and Vancomycin. The five levels demonstrate a linear relationship to each other for their respective analytes, reagents, and instruments.
This product may be used for proficiency testing in interlaboratory surveys and 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.
In addition, Level A – E of this product may be used as unassayed quality control material for these analytes or as an assayed quality control material for the analyzer systems specified in the package insert. It is not intended to be used as an assayed quality control material for any other analyzer systems.
Product codes (comma separated list FDA assigned to the subject device)
JJY
Device Description
The Audit™ MicroCV™ Therapeutic Drug (TDM) Linearity Set is a human based, lyophilized, five level set of QC material, with each level containing 14 analytes. It is used to confirm the proper calibration, linear operating range, and reportable range of Therapeutic Drug (TDM) methods for the analytes listed. 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 reconstituted stability and shelf life for the Audit™ MicroCV™ Therapeutic Drug (TDM) Linearity Set. All supporting data is retained on file at Aalto Scientific, Ltd. Product claims are as follows:
Reconstituted 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: Two years, when stored unopened 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.
0
Kord2714
Image /page/0/Picture/1 description: The image shows a logo for Aalto Scientific, Ltd. The logo consists of a triangular shape made up of many smaller triangles. The text "Aalto Scientific, Ltd" is written below the triangular shape.
NOV 1 9 2008
510(k) Summary
A. Submitter
Aalto Scientific, Ltd. 1959 Kellogg Ave. Carlsbad, CA 92008 Telephone: (760) 431-7922 Fax: (760) 431-6824
B. Contact Person
Brandon J Perez Telephone: (760) 431-7922 Ext. 120 E-mail: bperez@aaltoscientific.com
C. Date of Summary Preparation
September 13, 2008
D. Device Identification
Audit™ MicroCV™ Therapeutic Drug (TDM) Linearity Product Trade Name: Set Therapeutic Drug (TDM) Linearity Common Name: Assay QC Material Classification Name: Device Classification: Class I 21 CFR 862.1660 Regulation Number: 75 Panel: Product Code: JJY
E. Device to Which Substantial Equivalence is Claimed
Audit™ MicroCV™ 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 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 centrally beneath the triangular shape.
F. Description of the Device
The Audit™ MicroCV™ Therapeutic Drug (TDM) Linearity Set is a human based, lyophilized, five level set of QC material, with each level containing 14 analytes. It is used to confirm the proper calibration, linear operating range, and reportable range of Therapeutic Drug (TDM) methods for the analytes listed. 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.
G. Statement of Intended Use
The Therapeutic Drug (TDM) Linearity Set is intended to simulate human patient serum samples for the purpose of verifying and validating the Analytical Measurement Range for non-waived Therapeutic Drug (TDM) testing methods as identified in the package insert.
I. Summary of Performance Data
Stability studies have been performed to determine the reconstituted stability and shelf life for the Audit™ MicroCV™ Therapeutic Drug (TDM) Linearity Set. All supporting data is rctained on file at Aalto Scientific, Ltd. Product claims are as follows:
Reconstituted 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: Two years, when stored unopened 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 the logo for Aalto Scientific, Ltd. The logo features a stylized triangular shape above the company name. The triangular shape is composed of many smaller shapes, creating a textured effect. The text "Aalto Scientific, Ltd." is written in a simple, sans-serif font.
H. Technical Characteristics Compared to Predicate Device
| Characteristics | Audit™ MicroCV™ Therapeutic Drug
(TDM) Linearity Set
(New Device) | Audit™ MicroCV™ General Chemistry
Linearity Set
(K042318) |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Audit™ MicroCV™ Therapeutic Drug
(TDM) Linearity Set is assayed quality
control material consisting of human and
animal based serum albumin. 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. | 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 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
Analytes per vial | 14 | 30 |
| Number of levels
per set | 5 | 5 |
| Contents | 5 x 5 mL | 5 x 5 mL |
| Matrix | Human and animal based serum albumin | Human Based Serum |
| Type of Analytes | Therapeutic Drug | 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 |
| Reconstituted
Stability | 5 days at 2 to 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 the logo for Aalto Scientific, Ltd. The logo features a stylized triangular shape at the top, which appears to be composed of smaller geometric elements. Below the triangular shape, the text "Aalto Scientific, Ltd." is written in a simple, sans-serif font.
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 gencrated, the product is substantially equivalent to the predicate device.
4
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 features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Aalto Scientific Ltd. c/o Mr. Brandon J. Perez Research and Development Scientist 1959 Kellogg Avenue Carlsbad, CA 92008
NOV 1 9 2008
Re: K082714
Trade Name: Audit MicroCV Therapeutic Drug (TDM) Lincarity Set Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (assayed and unassayed). Regulatory Class: Class I, reserved Product Codes: JJY Dated: September 16, 2008 Received: September 18, 2008
Dear Mr. Perez:
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. Iisting 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); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820).
5
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.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.V.M.
Jean M. Cooper, M.S., D.V.M. 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): anknown KORLTIT
Device Name: Audit™ MicroCV™ Therapeutic Drug (TDM) Linearity Set
Indications For Use:
The Audit™ MicroCV™ Therapeutic Drug (TDM) Linearity Set consists of five levels in Human and Bovine serum albumin matrix. Each level contains the following analytes: Acetaminophen, Amikacin, Carbamazepine, Digoxin, Gentamicin, Methotrexate, Phenobarbital, Phenytoin, Quinidine, Salicylate, Theophylline, Tobramycin, Valoroic Acid and Vancomycin. The five levels demonstrate a linear relationship to each other for their respective analytes, reagents, and instruments.
This product may be used for proficiency testing in interlaboratory surveys and 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.
In addition, Level A – E of this product may be used as unassayed quality control material for these analytes or as an assayed quality control material for the analyzer systems specified in the package insert. It is not intended to be used as an assayed quality control material for any other analyzer systems.
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)
DYLAN DUGGAN
of In Viro Diagnostic Device and Sale