(268 days)
Not Found
No
The device is a quality control material for laboratory testing and the description does not mention any AI or ML components.
No.
This device is a quality control material used to monitor the precision of laboratory testing procedures, not to treat or diagnose a medical condition.
No
The device is a quality control material used to monitor the precision of laboratory testing procedures and confirm proper calibration. It does not directly diagnose disease or conditions in patients. While labeled "for In Vitro Diagnostic use only," this refers to its use within a diagnostic lab setting to ensure the accuracy of diagnostic tests.
No
The device is described as a "human based, liquid set of QC material," indicating it is a physical substance, 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® MicroLQ™ Spinal Fluid is for In Vitro Diagnostic use only."
- Purpose: The device is a quality control material intended for monitoring the precision of laboratory testing procedures. This aligns with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for diagnostic purposes. While this specific device isn't directly diagnosing a patient, it's used to ensure the accuracy of the tests that do provide diagnostic information.
- Device Description: The description details the analytes present in the material and its use in confirming the proper calibration of instruments used for testing these analytes in spinal fluid. This further supports its role in the in vitro diagnostic process.
N/A
Intended Use / Indications for Use
Audit® MicroLQ™ Spinal Fluid Control is a quality control material intended for monitoring the precision of laboratory testing procedures.
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® MicroLQ™ Spinal Fluid is for In Vitro Diagnostic use only.
Product codes
JJY
Device Description
The Audit® MicroLQ™ Spinal Fluid is a human based, liquid set of QC material. Each level of the set contains Chloride, Glucose, Immunoglobulin A (IgA), Immunoglobulin G (IgG), Immunoglobulin M (IgM), Lactate, Lactate Dehydogenase (LD), Microalbumin, Microprotein, and Sodium analytes. It is used to confirm the proper calibration of Chloride, Glucose, Immunoglobulin A (IgA), Immunoglobulin G (IgG), Immunoglobulin M (IgM), Lactate, Lactate Dehydogenase (LD), Microalbumin, Microprotein, and Sodium
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
laboratory
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
Stability studies have been performed to determine the shelf life for the Audit® MicroLQ™ Spinal Fluid Set. All supporting data is retained on file at Aalto Scientific. Ltd. Product claims are as follows:
Shelf Life: Two years, when stored unopened at 2 - 8º C.
Open Vial: 30 days, when stored at 2 - 8º C.
Note: Real time studies are ongoing to support the shelf life of this product.
Key Metrics
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/0 description: The image shows a sequence of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the numbers '112742'. The numbers are written in a simple, slightly irregular style, typical of handwriting.
Image /page/0/Picture/1 description: The image shows the logo for Aalto Scientific, Ltd. The logo features a stylized triangle composed of many small squares, resembling a mountain or pyramid. Below the triangle, the text "Aalto Scientific, Ltd" is printed in a simple, sans-serif font. The text is arranged on two lines, with "Aalto" on the first line and "Scientific, Ltd" on the second line.
510(k) Notification Audit® MicroLQ™ Spinal Fluid
JUN 1 5 2012
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
Dessi Lyakov Regulatory Affairs Manager Telephone: (760) 431-7922 Ext. 118 E-mail: dlyakov@aaltoscientific.com
C. Date of Summary Preparation
June 13, 2012
D. Device Identification
| Product Trade Name: | Audit® MicroLQ™ Spinal Fluid |
|---|---|
| Common Name: | Spinal Fluid |
| Classification Name: | Assay QC Material |
| Device Classification: | Class I |
| Regulation Number: | 21 CFR 862.1660 |
| Panel: | 75 |
| Product Code: | JJY |
Device to Which Substantial Equivalence is Claimed:
Audit® MicroCV™ Protein Linearity Set Product Trade Name: Aalto Scientific, Ltd., Carlsbad, CA K101216
E. Description of the Device
The Audit® MicroLQ™ Spinal Fluid is a human based, liquid set of QC material. Each level of the set contains Chloride, Glucose, Immunoglobulin A (IgA), Immunoglobulin G (IgG), Immunoglobulin M (IgM), Lactate, Lactate Dehydogenase (LD), Microalbumin, Microprotein, and Sodium analytes. It is used to confirm the proper calibration of Chloride, Glucose, Immunoglobulin A (IgA), Immunoglobulin G (IgG), Immunoglobulin M (IgM), Lactate, Lactate Dehydogenase (LD), Microalbumin, Microprotein, and Sodium
F. Statement of Intended Use
Audit® MicroLQ™ Spinal Fluid Control is a quality control material intended for monitoring the
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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 made up of many small dots, resembling a pyramid or mountain. Below the shape, the text "Aalto Scientific, Ltd." is written in a simple, sans-serif font.
510(k) Notification Audit® MicroLQ™ Spinal Fluid
precision of laboratory testing procedures.
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® MicroLQ™ Spinal Fluid is for In Vitro Diagnostic use only.
G. Summary of Performance Data
Stability studies have been performed to determine the shelf life for the Audit® MicroLQ™ Spinal Fluid Set. All supporting data is retained on file at Aalto Scientific. Ltd. Product claims are as follows:
Shelf Life: Two years, when stored unopened at 2 - 8º C.
Open Vial: 30 days, when stored at 2 - 8º 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 with a triangular shape at the top, resembling a mountain or pyramid, composed of many small dots. Below the logo, the text "Aulto Scientific, Ltd" is printed in a simple, sans-serif font. The text is slightly blurred, suggesting the image may be a scan or a low-resolution file.
510(k) Notification Audit® MicroLQ™ Spinal Fluid
H. Technical Characteristics Compared to Predicate Device
| Characteristics | Audit® MicroLQ™ Spinal Fluid Set (New Device) | Audit™ MicroCV™ Protein Linearity Set (K101216) |
|---|---|---|
| Intended Use | Audit® MicroLQ™ Spinal Fluid Control is a quality control material intended for monitoring the precision of laboratory testing procedures. | |
| 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® MicroLQ™ Spinal Fluid is for In Vitro Diagnostic use only. | Same | |
| Number of | ||
| Analytes per vial | 10 | 7 |
| Contents | 6 x 3 mL | 5 x 5 mL |
| Matrix | Human Based Serum | Same |
| Type of Analytes | Chloride, Glucose, Immunoglobulin A (IgA), Immunoglobulin G (IgG), Immunoglobulin M (IgM), Lactate, Lactate Dehydogenase (LD), Microalbumin, Microprotein, and Sodium | Alpha-1-Antitrypsin, Complement C3, Complement C4, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M and Transferrin |
| Form | Liquid | Same |
| Storage | 2 to 8º C | |
| Until expiration date | Same | |
| Open Bottle | ||
| Stability | 30 days at 2 to 8º C | 24 hours at 2 to 8º |
l. Conclusions
Based upon the purpose of the device and the descriptions of the predicate device, the safety and efficacy, and the stability data generated, the product is substantially equivalent to the oredicate device.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans and provide essential human services.
Food and Drug Administration
10903 New Hampshire Avenue Silver Spring, MD 20993
Aalto Scientific, Ltd. c/o Dessi Lyakov 1959 Kellogg Avenue Carlsbad, CA 92008
JUN 1 5 2012
Re: K112742
Trade Name: Audit® MicroLQTM Spinal Fluid Control Regulation Number: 21 CFR §862.1660 Regulation Name: Quality Control material (assayed and unassayed) Regulatory Class: Class I, reserved Product Codes: JJY Dated: April 23, 2012 Received: April 25, 2012
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.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical
Devices/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) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm
Sincerely yours,
Signature
Courney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510{k} Number: K112742
Device Name: AUDIT® MicroLQ™ Spinal Fluid Control Set
Indications For Use:
Audit® MicroLQ™ Spinal Fluid Control is a quality control material intended for monitoring the precision of laboratory testing procedures.
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® MicroLQ™ Spinal Fluid is for In Vitro Diagnostic use only.
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)
ORAL C
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
K 112742 510(k)