(38 days)
Not Found
No
The device description and intended use focus on a linearity set for immunoassay calibration verification and quality control, with no mention of AI or ML algorithms for data analysis, interpretation, or decision-making.
No
This device is an immunoassay linearity set used for proficiency testing, calibration verification, and quality control of laboratory instruments; it is not intended for the diagnosis, cure, mitigation, treatment, or prevention of disease.
No
This device is a linearity set and quality control material used for proficiency testing, calibration verification, and quality control of laboratory instruments measuring specific analytes, not for diagnosing patient conditions.
No
The device description clearly states it is a "Human and Bovine serum albumin based, lyophilized, five level set of QC material," indicating it is a physical product (reagents/controls) and not software.
Based on the provided text, this device is an IVD (In Vitro Diagnostic).
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". It also mentions use as "unassayed quality control material" and "assayed quality control material for the analyzer systems specified". These are all activities performed in vitro (outside the body) to assess the performance of diagnostic tests and instruments.
- Device Description: The description reinforces the intended use by stating it's a "QC material" used for "proficiency testing" and "calibration verification".
- Analytes: The product contains analytes like Cortisol, Digoxin, Estradiol, Ferritin, Folate, etc., which are commonly measured in clinical laboratories using in vitro diagnostic tests.
- Matrix: The product is in a "Human and Bovine serum albumin matrix", which is a common matrix for in vitro diagnostic controls and calibrators.
- Predicate Device: The listed predicate device (K042318 Audit™ MicroCV™ General Chemistry Linearity Set) is also a linearity set, which are typically classified as IVDs.
The core function of this device is to evaluate the performance and accuracy of other in vitro diagnostic tests and instruments. This aligns directly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Audit™ MicroCV™ Immunoassay Linearity Set consists of five levels in Human and Bovine serum albumin matrix. Each level contains the following analytes: Cortisol, Digoxin, Estradiol, Ferritin, Folate, Free T4, FSH, hCG, LH, Progesterone, Prolactin, Testosterone, Total PSA, Total T3, Total T4, TSH, and Vitamin B12. 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™ Immunoassay Linearity Set is a Human and Bovine serum albumin based, lyophilized, five level set of QC material, with each level containing 17 analytes It is used for proficiency testing in interlaboratory surveys and to perform CLIA directed calibration verification for the analytes listed using FDA accepted reagents for the appropriate instrumentation in accordance with current CLIA-88 guidelines and regulations. In apdrtions Level A ~ E of this product may be used as an unassayed quality control material for these analytes or as an assayed quality control material for the analyzer systems specified in the package insert. Where Level A is near the lower limit of instruments 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. It is not intended to be used as an assayed quality control material for any other analyzer systems.
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™ Immunoassay 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.
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Image /page/0/Picture/0 description: The image shows the logo for Aalto Scientific, Ltd. The logo consists of a triangle made up of many smaller triangles. Below the triangle is the text "Aalto Scientific, Ltd." in a serif font.
KCX62668
510(k) Summary
A. Submitter
Aalto Scientific, Ltd. 1959 Kellogg Ave. Carlsbad, CA 92008 Telephone: (760) 431-7922 Fax: (760) 431-6824
OCT 16 2006
B. Contact Person
Alan Vekich Regulatory Affairs Specialist Telephone: (760) 431-7922 ext. 120 E-mail: avekich@aaltoscientific.com
C. Date of Summary Preparation
September 2006
D. Device Identification
| Product Trade Name: |
|---|
| Common Name: |
| Classification Name: |
| Device Classification: |
| Regulation Number: |
| Panel: |
| Product Code: |
Audit™ MicroCVTM Immunoassay Linearity Set Immunoassay Linearity Assay QC Material Class I 21 CFR 862.1660 75 JJY
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 the logo for Aalto Scientific, Ltd. The logo features a triangular shape made up of many small dots, resembling a stylized mountain or pyramid. Below the triangular shape, the text "Aalto Scientific, Ltd." is printed in a simple, sans-serif font.
F. Description of the Device
The Audit™ MicroCV™ Immunoassay Linearity Set is a Human and Bovine serum albumin based, lyophilized, five level set of QC material, with each level containing 17 analyters It is used for proficiency testing in interlaboratory surveys and to perform CLIA directed calibration verification for the analytes listed using FDA accepted reagents for the appropriate instrumentation in accordance with current CLIA-88 guidelines and regulations. In apdrtions Level A ~ E of this product may be used as an unassayed quality control material for these analytes or as an assayed quality control material for the analyzer systems specified in the package insert. Where Level A is near the lower limit of instruments 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. It is not intended to be used as an assayed quality control material for any other analyzer systems.
G. Statement of Intended Use
The Immunoassay Linearity Set is intended to simulate human patient serum samples for the purpose of verifying and validating the Analytical Measurement Range for non-waived immunoassay testing methods as identified in the package insert.
| Characteristics | Audit™ MicroCV™ Immunoassay
Linearity Set
(New Device) | Audit™ MicroCV™ General Chemistry
Linearity Set
(K042318) |
|--------------------------------|--------------------------------------------------------------|-----------------------------------------------------------------------------|
| Intended Use | Linear, calibration verification quality
control material | Linear, calibration verification quality
control material |
| Number of
Analytes per vial | 17 | 30 |
| Number of levels
per set | 5 | 5 |
| Contents | 5 x 5 mls | 5 x 5 mls |
| Matrix | Human and Bovine Serum Albumin | Human Based Serum |
| Type of Analytes | Immunoassay | General Chemistry |
| Form | Lyophilized | Lyophilized |
| Preservative | Yes | Yes |
| 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 |
H. Technical Characteristics Compared to Predicate Device
K062668 Pg 2 of 3
2
Image /page/2/Picture/0 description: The image shows a logo for Aalto Scientific, Ltd. The logo features a triangular shape composed of many small circles or dots, creating a textured effect. Below the triangular shape, the text "Aalto Scientific, Ltd." is written in a simple, sans-serif font.
I. Summary of Performance Data
Stability studies have been performed to determine the reconstituted stability and shelf life for the Audit™ MicroCV™ Immunoassay 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.
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
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Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Alan Vekich Regulatory Affairs Specialist Aalto Scientific, Ltd. 1959 Kellogg Ave. Carlsbad. CA 92008
OCT 1 6 2006
Re: K062668 Trade/Device Name: Audit™ MicroCV™ Immunoassay Linearity Set Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: September 8, 2006 Received: September 13, 2006
Dear Mr. Vekich:
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 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 (QS) regulation (21 CFR Part 820).
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Page 2 -
This letter will allow you to begin marketing your device as described in your Section $10(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) 276-0484. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Alberto Gutz
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K 062 1268
Audit™ MicroCV™ Immunoassay Linearity Set Device Name:
Indications For Use:
The Audit™ MicroCV™ Immunoassay Linearity Set consists of five levels in Human and Bovine serum albumin matrix. Each level contains the following analytes: Cortisol, Digoxin, Estradiol, Ferritin, Folate, Free T4, FSH, hCG, LH, Progesterone, Prolactin, Testosterone, Total PSA, Total T3, Total T4, TSH, and Vitamin B12. 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)