(130 days)
Not Found
No
The device is a quality control material for laboratory assays and does not involve data processing or algorithmic analysis.
No.
This device is a control material used for monitoring the precision of laboratory testing procedures (quality control), not for treating any disease or condition.
No
This device is described as a "control" and is "intended to simulate human patient samples for the purpose of monitoring the precision of laboratory testing procedures." It is used for "quality control purposes" and to "confirm the proper calibration" of assays, which means it helps ensure that other diagnostic tests are working correctly, rather than being a diagnostic device itself. The text explicitly states it is "for In Vitro Diagnostic use only," but in the context of being a control for diagnostic assays, not a diagnostic device itself.
No
The device description clearly states it is 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).
The document explicitly states: "The Audit® MicroLQ™ Serum Protein Control is for In Vitro Diagnostic use only."
Furthermore, the intended use and device description clearly indicate that it is a control material used in laboratory testing procedures to monitor the precision of assays designed to quantitate various proteins in human serum. This aligns with the definition of an in vitro diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for Use
Audit® MicroLQ™ Serum Protein Control is an assayed, ready-to-use liquid, bi-level, human Adults histor control for use with assays designed to quantitate: Immunoglobulin E (IgE), Scrain Baoou oonliron (IgM), Immunoglobulin G (IgG), Immunoglobulin A (IgA), Prealbumin, inindhoglobalin willing sin (ART), Albumin, Complement C4 (C4), Complement C3 (C3), alpha-2-Macroglobulin, Alpha-1-Acid Glycoprotein, Ceruloplasmin, (OD), alphia E Macroglobulin. It is intended to simulate human patient samples for r haptoglobin, and bota in the grecision of laboratory testing procedures for Immunoglobulin E (IgE), Immunoglobulin M (IgM), Immunoglobulin G (IgG), Immunoglobulin A (IgA), (192) minin, Antithrombin III, Alpha-1-Antitrypsin (AAT), Albumin, Complement C4 (C4), Prodiburnin, Anaka-Macroglobulin, Alpha-1-Acid Glycoprotein, Ceruloplasmin, Oomplomorit 00 (00), and Beta-2-Microglobulin assays. When used for quality control rransfermir, huptoglobin, and both ach laboratory establish its own means and acceptable purposes, it is roommended this a may as guides. The product is intended for use with quantitative assays on the Beckman Immage 800.
Product codes (comma separated list FDA assigned to the subject device)
JJY
Device Description
The Audit® MicroLQ™ Serum Protein Control is a human based, liguid set of QC material. Each level of the set contains Immunoglobulin E (IgE), Immunoglobulin M (IgM), Immunoglobulin G (IgG), Immunoglobulin A (IgA), Prealbumin, Antithrombin III, Alpha-1-Antitrypsin (AAT), Albumin, Complement C4 (C4), Complement C3 (C3), alpha-2-Macroclobulin, Alpha-1-Acid Glycoprotein, Ceruloplasmin, Transferrin, Haptoglobin, and Beta-2-Microglobulin analytes. It is used to confirm the proper calibration of Immunoclobulin E (IgE), Immunoglobulin M (IgM), Immunoglobulin G (IgG), Immunoglobulin A (IgA), Prealbumin, Antithrombin III. Alpha-1-Antitrypsin (AAT), Albumin, Complement C4 (C4), Complement C3 (C3), alpha-2-Macroglobulin, Alpha-1-Acid Glycoprotein, Ceruloplasmin, Transferrin, Haptoglobin, and Beta-2-Microglobulin.
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 shelf life for the Audit® MicroLQ™ Serum Protein Control Set. All supporting data is retained on file at Aalto Scientific, Ltd. Product claims are as follows: Shelf Life: Three years, when stored unopened at 2 - 8º C.
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/1 description: The image shows a logo for Aalto Scientific, Ltd. The logo features a triangular shape at the top, composed of many small dots. Below the triangle, the text "Aalto Scientific, Ltd." is written in a serif font.
510(k) Summary
JAN 2 4 2012
A. Submitter
Aalto Scientific, Ltd. 1959 Kelloag Ave. Carlsbad, CA 92008 Telephone: (760) 431-7922 (760) 431-6824 Fax:
B. Contact Person
Dessi Lyakov Regulatory Affairs Manager Telephone: (760) 431-7922 Ext. 118 E-mail: dlyakov@aaltoscientific.com
C. Date of Summary Preparation
January 11, 2012
D. Device Identification
| Product Trade Name: | Audit® MicroLQT™ Serum Protein Control |
|---|---|
| Common Name: | Serum Protein Control |
| 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: | |
| Product Trade Name: | Audit® MicroCV™ Protein Linearity Set |
| Aalto Scientific, Ltd., Carlsbad, CA | |
| K101316 |
E. Description of the Device
The Audit® MicroLQ™ Serum Protein Control is a human based, liguid set of QC material. Each level of the set contains Immunoglobulin E (IgE), Immunoglobulin M (IgM), Immunoglobulin G (IgG), Immunoglobulin A (IgA), Prealbumin, Antithrombin III, Alpha-1-Antitrypsin (AAT), Albumin, Complement C4 (C4), Complement C3 (C3), alpha-2-Macroclobulin, Alpha-1-Acid Glycoprotein, Ceruloplasmin, Transferrin, Haptoglobin, and Beta-2-Microglobulin analytes. It is used to confirm the proper calibration of Immunoclobulin E (IgE), Immunoglobulin M (IgM), Immunoglobulin G (IgG), Immunoglobulin A (IgA), Prealbumin, Antithrombin III. Alpha-1-Antitrypsin (AAT), Albumin, Complement C4 (C4), Complement C3 (C3), alpha-2-Macroglobulin, Alpha-1-Acid Glycoprotein, Ceruloplasmin, Transferrin, Haptoglobin, and Beta-2-Microglobulin.
1
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F. Statement of Intended Use
Audit® MicroLQ™ Serum Protein Control is an assayed, ready-to-use liquid, bi-level, human serum -based control for use with assays designed to quantitate: Immunoglobulin E (IgE), Immunoglobulin M (IgM), Immunoalobulin G (IgG), Immunoqlobulin A (IgA), Prealbumin, Antithrombin III. Alpha-1-Antitrypsin (AAT). Albumin. Complement C4 (C4). Complement C3 (C3), alpha-2-Macroglobulin, Alpha-1-Acid Glycoprotein, Ceruloplasmin, Transferrin, Haptoglobin, and Beta-2-Microglobulin. It is intended to simulate human patient samples for the purpose of monitoring the precision of laboratory testing procedures for Immunoglobulin E (IgE), Immunoglobulin M (IgM), Immunoglobulin G (IgG), Immunoglobulin A (IgA), Prealbumin, Antithrombin III, Alpha-1-Antitrypsin (AAT), Albumin, Complement C4 (C4), Complement C3 (C3), alpha-2-Macroglobulin, Alpha-1-Acid Glycoprotein, Ceruloplasmin, Transferrin, Haptoglobin, and Beta-2-Microglobulin assays. 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 Beckman Immage 800
The Audit® MicroLQ™ Serum Protein Control 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™ Serum Protein Control Set. All supporting data is retained on file at Aalto Scientific, Ltd. Product claims are as follows:
Shelf Life: Three years, when stored unopened at 2 - 8º C.
Note: Real time studies are ongoing to support the shelf life of this product.
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H. Technical Characteristics Compared to Predicate Device
| Characteristics | Audit® MicroLQ™ Serum Protein Control Set
(K112705) | Audit™ MicroCV™ Protein Linearity Set
(K101216) |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Audit® MicroLQ™ Serum Protein Control is an
assayed, ready-to-use liquid, bi-level, human serum
-based control for use with assays designed to
quantitate: Immunoglobulin E (IgE), Immunoglobulin
M (IgM), Immunoglobulin G (IgG), Immunoglobulin A
(IgA), Prealbumin, Antithrombin III, Alpha-1-
Antitrypsin (AAT), Albumin, Complement C4 (C4),
Complement C3 (C3), alpha-2-Macroglobulin, Alpha-
1-Acid Glycoprotein, Ceruloplasmin, Transferrin,
Haptoglobin, and Beta-2-Microglobulin. It is intended
to simulate human patient samples for the purpose
of monitoring the precision of laboratory testing
procedures for Immunoglobulin E (IgE),
Immunoglobulin M (IgM), Immunoglobulin G (IgG),
Immunoglobulin A (IgA), Prealbumin, Antithrombin III,
Alpha-1-Antitrypsin (AAT), Albumin, Complement C4
(C4), Complement C3 (C3), alpha-2-Macroglobulin,
Alpha-1-Acid Glycoprotein, Ceruloplasmin,
Transferrin, Haptoglobin, and Beta-2-Microglobulin
assays. 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 Beckman
Immage 800
The Audit® MicroLQ™ Serum Protein Control is for
In Vitro Diagnostic use only. | The Audit™ MicroCV™ Protein Linearity is
assayed quality control material consisting of
five levels protein (human) based serum. Each
level contains Alpha-1-Antitrypsin, Complement
C3, Complement C4, Immunoglobulin G,
Immunoglobulin A, Immunoglobulin M and
Transferrin analytes. The five levels
demonstrate a linear relationship to each other
for Alpha-1-Antitrypsin, Complement C3,
Complement C4, Immunoglobulin G,
Immunoglobulin A, Immunoglobulin M, and
Transferrin analytes. It is intended to simulate
human patient serum samples and to detect
systematic analytical deviations of laboratory
testing procedures for Alpha-1-Antitrypsin,
Complement C3, Complement C4,
Immunoglobulin G, Immunoglobulin A,
Immunoglobulin M, and Transferrin. The
product is intended for use with quantitativ
assays on the indicated analyzer provided in
the labeling. The Audit MicroCV Protein
Linearity Set is "For In Vitro Diagnostic Use
Only." |
| Number of Analytes
per vial | 16 | 7 |
| Contents | 6 x 2 mL | 5 x 2 mL |
| Matrix | Human Based Serum | Human Based Serum |
| Type of Analytes | Immunoglobulin E (IgE), Immunoglobulin M (IgM),
Immunoglobulin G (IgG), Immunoglobulin A (IgA),
Prealbumin, Antithrombin III, Alpha-1-Antitrypsin
(AAT), Albumin, Complement C4 (C4), Complement
C3 (C3), alpha-2-Macroglobulin, Alpha-1-Acid
Glycoprotein, Ceruloplasmin, Transferrin,
Haptoglobin, and Beta-2-Microglobulin. | Alpha-1-Antitrypsin, Complement C3,
Complement C4, Immunoglobulin G,
Immunoglobulin A, Immunoglobulin M and
Transferrin |
| Form | Liquid | Liquid |
| Storage | 2 to 8° C Until expiration date | 2 to 8° C Until expiration date |
| Open Bottle
Stability | 36 months at 2 to 8° C | 24 hours at 2 to 8° C |
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 predicate 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" around the perimeter. Inside the circle is an abstract symbol resembling a stylized human figure with outstretched arms.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Aalto Scientific, Ltd. c/o Dessi Lyakov Manager, Regulatory Affairs 1959 Kellogg Avenue Carlsbad, CA 92008
JAN 2 4 2012
Re: K112705
Trade/Device Name: Audit® MicroLQ™ Serum Protein Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (Assayed and Unassayed) Regulatory Class: I Product Code: JJY Dated: November 22, 2011 Received: November 23, 2011
Dear Ms. 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 class II (Special Controls), it may be subject to such 11 Jour de roottols. 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 corply 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
4
Page 2 – Ms. Dessi Lyakov
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 nredicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), 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 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/cdrh/industry/support/index.html.
Sincerely yours,
Reena Philip
Maria M. Chan, Ph.D. Director, Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number: K112705
Device Name: AUDIT® MicroLQ™ Serum Protein Control
Indications For Use:
Audit® MicroLQ™ Serum Protein Control is an assayed, ready-to-use liquid, bi-level, human Adults histor control for use with assays designed to quantitate: Immunoglobulin E (IgE), Scrain Baoou oonliron (IgM), Immunoglobulin G (IgG), Immunoglobulin A (IgA), Prealbumin, inindhoglobalin willing sin (ART), Albumin, Complement C4 (C4), Complement C3 (C3), alpha-2-Macroglobulin, Alpha-1-Acid Glycoprotein, Ceruloplasmin, Transferrin, (OD), alphia E Macroglobulin. It is intended to simulate human patient samples for r haptoglobin, and bota in the grecision of laboratory testing procedures for Immunoglobulin E (IgE), Immunoglobulin M (IgM), Immunoglobulin G (IgG), Immunoglobulin A (IgA), (192) minin, Antithrombin III, Alpha-1-Antitrypsin (AAT), Albumin, Complement C4 (C4), Prodiburnin, Anaka-Macroglobulin, Alpha-1-Acid Glycoprotein, Ceruloplasmin, Oomplomorit 00 (00), and Beta-2-Microglobulin assays. When used for quality control rransfermir, huptoglobin, and both ach laboratory establish its own means and acceptable purposes, it is roommended this a may as guides. The product is intended for use with quantitative assays on the Beckman Immage 800.
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)
Division Sitar Off Office of In Vitro
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K112705