(130 days)
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® MicroLQ™ Serum Protein Control is a human based, liquid 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-Macroglobulin, Alpha-1-Acid Glycoprotein, Ceruloplasmin, Transferrin, Haptoglobin, and Beta-2-Microglobulin analytes. It is used to confirm the proper calibration of 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.
The provided document describes the Audit® MicroLQ™ Serum Protein Control, which is a quality control material, not a device that generates diagnostic results. Therefore, the typical acceptance criteria and study designs for diagnostic devices (like sensitivity, specificity, agreement with ground truth, comparative effectiveness with human readers, etc.) are not applicable in this context.
Instead, the performance data presented is focused on the stability of the control material.
Here's a breakdown of the requested information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Shelf Life (unopened) | Three years, when stored unopened at 2 - 8º C. |
| Open Bottle Stability | 36 months at 2 to 8º C (as compared to the predicate's 24 hours). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a "test set" in the traditional sense. The data relates to the stability of the control material itself. The document states "All supporting data is retained on file at Aalto Scientific, Ltd."
- Data Provenance: The studies were performed by Aalto Scientific, Ltd., located in Carlsbad, CA, USA. This indicates the data is likely retrospective for initial claims and "real-time studies are ongoing" for further support.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable as the device is a control material, not a diagnostic device requiring expert interpretation for ground truth establishment. The "truth" for a control material would be its manufacturing specifications and its demonstrated stability.
4. Adjudication Method for the Test Set
Not applicable for a control material stability study.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-powered diagnostic device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance of this control material is its chemical stability and its ability to maintain its assayed values over time under specified storage conditions. This is established through analytical testing of the control material itself at various time points and conditions.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that requires a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable.
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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 SetAalto Scientific, Ltd., Carlsbad, CAK101316 |
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.
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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 anassayed, ready-to-use liquid, bi-level, human serum-based control for use with assays designed toquantitate: Immunoglobulin E (IgE), ImmunoglobulinM (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 intendedto simulate human patient samples for the purposeof monitoring the precision of laboratory testingprocedures 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-Microglobulinassays. When used for quality control purposes, it isrecommended that each laboratory establish its ownmeans and acceptable ranges and use the valuesprovided only as guides. The product is intended foruse with quantitative assays on the BeckmanImmage 800The Audit® MicroLQ™ Serum Protein Control is forIn Vitro Diagnostic use only. | The Audit™ MicroCV™ Protein Linearity isassayed quality control material consisting offive levels protein (human) based serum. Eachlevel contains Alpha-1-Antitrypsin, ComplementC3, Complement C4, Immunoglobulin G,Immunoglobulin A, Immunoglobulin M andTransferrin analytes. The five levelsdemonstrate a linear relationship to each otherfor Alpha-1-Antitrypsin, Complement C3,Complement C4, Immunoglobulin G,Immunoglobulin A, Immunoglobulin M, andTransferrin analytes. It is intended to simulatehuman patient serum samples and to detectsystematic analytical deviations of laboratorytesting procedures for Alpha-1-Antitrypsin,Complement C3, Complement C4,Immunoglobulin G, Immunoglobulin A,Immunoglobulin M, and Transferrin. Theproduct is intended for use with quantitativassays on the indicated analyzer provided inthe labeling. The Audit MicroCV ProteinLinearity Set is "For In Vitro Diagnostic UseOnly." |
| Number of Analytesper 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), ComplementC3 (C3), alpha-2-Macroglobulin, Alpha-1-AcidGlycoprotein, Ceruloplasmin, Transferrin,Haptoglobin, and Beta-2-Microglobulin. | Alpha-1-Antitrypsin, Complement C3,Complement C4, Immunoglobulin G,Immunoglobulin A, Immunoglobulin M andTransferrin |
| Form | Liquid | Liquid |
| Storage | 2 to 8° C Until expiration date | 2 to 8° C Until expiration date |
| Open BottleStability | 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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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
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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
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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
§ 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.