(48 days)
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No
The document describes a linearity set for laboratory testing of lipids, focusing on calibration verification and quality control. There is no mention of AI or ML in the intended use, device description, or performance studies. The device is a physical control material, not a software or analytical tool that would typically incorporate AI/ML.
No
This device is a linearity set and quality control material used for laboratory testing of lipids, not for direct therapeutic intervention on a patient.
No
This device is a linearity set and quality control material used to verify the performance of other diagnostic devices, not to diagnose patients directly.
No
The device description clearly states it is a "human based, lyophilized, five level set of QC material," indicating it is a physical product, not software.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's 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". These are all activities performed in vitro (outside the body) to assess the performance of diagnostic tests.
- Device Description: The description states it's a "human based, lyophilized, five level set of QC material" used to "confirm the proper calibration, linear operating range, and reportable range of Lipids methods for the analytes listed". This further reinforces its role in evaluating the performance of diagnostic assays.
- Care Setting: The intended user/care setting is "Laboratory testing procedures", which is where IVD tests are performed.
While the document doesn't explicitly use the term "IVD", the described function and intended use clearly align with the definition of an In Vitro Diagnostic device. It is a reagent/material used to assess the performance of other diagnostic tests performed on biological samples.
N/A
Intended Use / Indications for Use
The Lipids Linearity Set is intended to simulate human patient serum samples for the purpose of verifying and validating the Analytical Measurement Range for non-waived Lipids testing methods as identified in the package insert.
The Audit™ MicroCV™ Lipids Linearity Set (Low) consists of five levels. Each level contains the following analytes: Apolipoprotein A1, Apolipoprotein B, Cholesterol, HDL Cholesterol. LDL Cholesterol and Triglyceride and 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™ Lipids Linearity Set (Low) is a human based, Iyophilized, five level set of QC material, with each level containing 6 analytes. It is used to confirm the proper calibration, linear operating range, and reportable range of Lipids 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
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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 reconstituted stability and shelf life for the Audit™ MicroCVTM Lipids Linearity Set (Low). 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 24 hours 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.)
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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).
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§ 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 a handwritten sequence of characters and numbers. The sequence starts with the letters 'KO', followed by the numbers '70223'. The handwriting is somewhat rough, with thick strokes, and the characters are closely spaced together.
Image /page/0/Picture/1 description: The image shows a logo for Aalto Scientific, Ltd. The logo features a triangular shape composed of many small dots, resembling a pyramid or mountain. Below the triangular shape, the text "Aalto Scientific, Ltd." is written in a simple, sans-serif font. The overall design is clean and minimalist.
510(k) Summary
A. Submitter
MAR 1 3 2007
Aalto Scientific, Ltd. 1959 Kellogg Ave. Carlsbad, CA 92008 (760) 431-7922 Telephone: (760) 431-6824 Fax:
B. Contact Person
Alan Vekich ي س Regulatory Affairs Specialist (760) 431-7922 ext. 12 1760) Telephone: avekich@aaltoscientific.com E-mail:
C. Date of Summary Preparation
December 1, 2006
D. Device Identification
| Product Trade Name: | Audit™ MicroCV™ Lipids Linearity Set (Low) |
|---|---|
| Common Name: | Lipids Linearity |
| Classification Name: | Assay QC Material |
| Device Classification: | Class I |
| Regulation Number: | 21 CFR 862.1660 |
| Panel: | 75 |
| Product Code: | JJY |
E. Device to Which Substantial Equivalence is Claimed
Audit™ MicroCVTM 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 stylized triangular shape at the top, composed of many small dots or squares, giving it a textured appearance. 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™ Lipids Linearity Set (Low) is a human based, Iyophilized, five level set of QC material, with each level containing 6 analytes. It is used to confirm the proper calibration, linear operating range, and reportable range of Lipids 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 Lipids Linearity Set is intended to simulate human patient serum samples for the purpose of verifying and validating the Analytical Measurement Range for non-waived Lipids 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™ MicroCVTM Lipids Linearity Set (Low). 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 24 hours 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 consists of the text "Aalto Scientific, Ltd." in a simple font, with the "A" in "Aalto" slightly larger than the other letters. Above the text is a triangular shape made up of many small circles or dots, creating a textured, pyramid-like design.
H. Technical Characteristics Compared to Predicate Device
| Characteristics | Audit™ MicroCV™ Lipids Linearity Set
(Low)
(New Device) | Audit™ MicroCV™ General Chemistry
Linearity Set
(K042318) |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Audit™ MicroCV™ Lipids Linearity Set
(Low) is assayed quality control material
consisting of Delipidized Human 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 inter-laboratory 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 inter-laboratory 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 | 6 | 30 |
| Number of levels
per set | 5 | 5 |
| Contents | 5 x 2 mls | 5 x 5 mls |
| Matrix | Delipidized Human Serum | Human Based Serum |
| Type of Analytes | Lipids | General Chemistry |
| Form | Lyophilized | Lyophilized |
| Stabilizers | Sucrose | None |
| Preservatives | Sorbitol | Sorbitol |
| Storage | 2 to 8° C
Until expiration date | 2 to 8° C
Until expiration date |
| Reconstituted
Stability | 24 hours at 2 to 8° C | 24 hours at 2 to 8° C |
·
3
Image /page/3/Picture/0 description: The image shows the logo for Aalto Scientific, Ltd. The logo features a triangular shape at the top, composed of many small dots. Below the triangular shape, the text "Aalto Scientific, Ltd." is written in a simple, sans-serif font. The text is left-aligned and positioned directly under the triangular shape.
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.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The background is white.
Public Health Service
Food and Druq Administration 2098 Gaither Road Rockville MD 20850
Aalto Scientific, Ltd. c/o Mr. Alan Vekich Regulatory Affairs Specialist 1959 Kellogg Avenue Carlsbad, CA 92008
MAR 1 3 2007
Re: K070223 Trade/Device Name: Audit™ Microcv™ Lipids Linearity Set (Low) Regulation Number: 21 CFR§862.1660 Regulation Name: Quality control material (assayed and unassayed). Regulatory Class: Class I Product Code: JJY Dated: January 17, 2007 Received: January 24, 2007
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 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.
Yean 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
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Indications for Use
510(k) Number (if known): unknown
Device Name: Audit™ MicroCV™ Lipids Linearity Set (Low)
Indications For Use:
The Audit™ MicroCV™ Lipids Linearity Set (Low) consists of five levels. Each level contains the following analytes: Apolipoprotein A1, Apolipoprotein B, Cholesterol, HDL Cholesterol. LDL Cholesterol and Triglyceride and 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 (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 Benson
Sign-Off
ffice of In Vitro Diagnostic Device Valuation and Safety