(189 days)
Audit® MicroCV™ T-Uptake Calibration/Verification Set consists of five levels of human and bovine albumin based serum containing T-Uptake. The Audit® MicroCV™ T-Uptake Calibration/Verification Set is a quality control material intended for use in the quantitative verification of calibration and reportable range of the Roche T-uptake Assay when performed on the P-Modular Analyzer 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® MicroCV™ T-Uptake Calibration/Verification is for In Vitro Diagnostic use only.
The Audit® MicroCV™ T-Uptake Calibration/Verification is a human and bovine albumin based, liquid set of QC material. Each level of the set contains T-Uptake analyte. It is used to confirm the proper calibration, linear operating range, and reportable range of T-Uptake. Level A is near the lower limit level and Level E has concentrations near the upper limit of P-Modular analyzer. Levels B, C, and D are prepared in a manner such that an equal distance exists between each consecutive level.
The provided document describes the Aalto Scientific, Ltd. Audit® MicroCV™ T-Uptake Calibration/Verification Set, a quality control material intended for use in the quantitative verification of calibration and reportable range of the Roche T-uptake Assay when performed on the P-Modular Analyzer.
However, the document focuses on demonstrating substantial equivalence to a predicate device rather than presenting acceptance criteria and a detailed study proving the device meets those criteria.
Here's an analysis of the provided information concerning acceptance criteria and study data:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly provide a table of acceptance criteria for the "Audit® MicroCV™ T-Uptake Calibration/Verification Set" itself in terms of performance metrics like accuracy, precision, or detection limits. Instead, it focuses on the equivalence of its characteristics to a predicate device and stability claims.
The closest we get to "performance" are the stability claims.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Stability - Open Bottle: | 10 days, when stored at 2 - 8° C. |
| Stability - Shelf Life: | Two Years, when stored unopened at 2 - 8° C. |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "Stability studies have been performed" but does not specify the sample size used for these studies. It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not applicable to this type of device and study. The device is a quality control material, and its performance is assessed through analytical stability, not through expert-reviewed ground truth on patient samples.
4. Adjudication Method for the Test Set:
This information is not applicable as there is no mention of expert review or adjudication in the context of this device's testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. This type of study is typically relevant for interpretative diagnostic devices where human readers evaluate cases with and without AI assistance. This device is a quality control material, not an interpretive diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No, a standalone algorithm performance study was not done. The device itself is a physical quality control material, not an algorithm. Its performance is related to its stability and ability to verify calibration, not an algorithm's output.
7. The Type of Ground Truth Used:
For the stability studies, the "ground truth" would be the expected concentration values of T-Uptake in the quality control material at different time points, as determined by a reference method or validated assay. The document implies that measurement against these established values forms the basis of the stability assessment.
8. The Sample Size for the Training Set:
This information is not applicable. The device is a quality control material, not a machine learning algorithm. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set was Established:
This information is not applicable as there is no training set.
Summary of the Study and "Acceptance" for K112143:
The document primarily focuses on demonstrating substantial equivalence to the predicate device, Audit® MicroCV™ Immunoassay Linearity Set (K062668), based on comparable technical characteristics and intended use.
The study that supports the device's claims is stability testing, which aimed to determine the shelf life and open-bottle stability of the Audit® MicroCV™ T-Uptake Calibration/Verification Set.
- Study Design: Implied to be real-time stability studies.
- "Acceptance Criteria" for Stability: The primary "acceptance criteria" presented are the defined stability periods:
- Open Bottle: 10 days at 2 - 8° C.
- Shelf Life: Two Years (unopened) at 2 - 8° C.
- "Study Results" (Reported Performance): The document states that "All supporting data is retained on file at Aalto Scientific, Ltd." and explicitly claims the "Product claims are as follows" with the listed stability periods. This indicates that the conducted stability studies demonstrated performance meeting these stated claims.
- Data Detail: The submission states that supporting data for stability is "retained on file." No specific raw data, statistical analysis, or detailed breakdown of the stability study's methodology (e.g., number of batches tested, frequency of testing, acceptance criteria for allowable drift) is provided in this summary.
In essence, the "study" is the internal stability testing, and the "acceptance criteria" are the target stability durations. The declared performance indicates these criteria were met, leading to the substantial equivalence determination by the FDA.
{0}------------------------------------------------
JAN 3 1 2012
Image /page/0/Picture/2 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. The text is left-aligned and appears to be the name of the company.
510(k) Notification Audit® MicroCV™ T-Uptake Calibration/Verification Set
510(k) Summarv
A. Submitter
Aalto Scientific. Ltd. 1959 Kelloga 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
January 30, 2012
D. Device Identification
| Product Trade Name: | Audit® MicroCV TM T-Uptake Calibration/Verification Set |
|---|---|
| Common Name: | T-Uptake Calibration/Verification |
| Classification Name: | Assay QC Material |
| Device Classification: | Class I |
| Regulation Number: | 21 CFR 862.1660 |
| Panel: | 75 |
| Product Code: | JJX |
Device to Which Substantial Equivalence is Claimed:
Audit® MicroCV™ Immunoassay Linearity Set Product Trade Name: Aalto Scientific, Ltd., Carlsbad, CA K062668
E. Description of the Device
The Audit® MicroCV™ T-Uptake Calibration/Verification is a human and bovine albumin based, liquid set of QC material. Each level of the set contains T-Uptake analyte. It is used to confirm the proper calibration, linear operating range, and reportable range of T-Uptake. Level A is near the lower limit level and Level E has concentrations near the upper limit of P-Modular analyzer. Levels B, C, and D are prepared in a manner such that an equal distance exists between each consecutive level.
F. Statement of Intended Use
Audit® MicroCV™ T-Uptake Calibration/Verification Set consists of five levels of human and bovine albumin based serum containing T-Uptake. The Audit® MicroCV™ T-Uptake Calibration/Verification Set is a quality control material intended for use in the quantitative verification of calibration and reportable range of the Roche T-uptake Assay when performed on the P-Modular Analyzer When used for quality control purposes, it is recommended that each laboratory establish its own means and acceptable ranges and use the values provided
{1}------------------------------------------------
Image /page/1/Picture/0 description: The image shows a logo for Aalto Scientific, Ltd. The logo consists of a triangular shape made up of many small dots. Below the triangle, the text "Aalto Scientific, Ltd." is written in a simple font. The text is left-aligned with the triangle.
510(k) Notification Audit® MicroCV™ T-Uptake Calibration/Verification Set
only as guides. The Audit® MicroCV™ T-Uptake Calibration/Verification is for In Vitro Diagnostic use only.
A. Summary of Performance Data
Stability studies have been performed to determine the shelf life for the Audit® MicroCV™ T-Uptake Calibration/Verification Set. All supporting data is retained on file at Aalto Scientific, Ltd. Product claims are as follows:
Open Bottle: 10 days, when stored 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 a logo for Aalto Scientific, Ltd. The logo features a triangular shape at the top, composed of many small circles or dots. Below the triangular shape, the text "Aalto Scientific, Ltd." is written in a serif font. The text is arranged in two lines, with "Aalto Scientific," on the first line and "Ltd." on the second line.
510(k) Notification Audit® MicroCV™ T-Uptake Calibration/Verification Set
B. Technical Characteristics Compared to Predicate Device
| Characteristics | Audit® MicroCV™ T-UptakeCalibration/Verification Set(K112143) | Audit™ MicroCV™ ImmunoassayLinearity Set(K062668) |
|---|---|---|
| Intended Use | Audit® MicroCV™ T-UptakeCalibration/Verification Set consists of fivelevels of human and bovine albumin basedserum containing T-Uptake. The Audit®MicroCV™ T-Uptake Calibration/Verification Setis a quality control material intended for use inthe quantitative verification of calibration andreportable range of the Roche T-uptake Assaywhen performed on the P-Modular AnalyzerWhen used for quality control purposes, it isrecommended that each laboratory establish itsown means and acceptable ranges and use thevalues provided only as guides. The Audit®MicroCV™ T-Uptake Calibration/Verification isfor In Vitro Diagnostic use only. | The Audit® MicroCV™ Immunoassay Linearityconsist of five levels of human and bovineserum albumin matrix. Each level contains thefollowing analytes: Cortisol, Digoxin, Estradiol,Ferritin, Folate, Free T4, FSH, hCG, LH,Progesterone, Prolactin, Testosterone, TotalPSA, Total T3, Total T4,TSH, and Vitamin B12.These five levels demonstrate a linearrelationship to each other for their respectiveanalytes, reagents, and instruments.This product may be used for proficiency testingin interlaboratory surveys and to perform CLIAdirected calibration verification for these sameanalytes in accordance with current CLIA-88guidelines and regulations.In addition, level A-E of this product may beused as unassayed quality control material forthese analytes or as an assayed quality controlmaterial for the analyzer systems specified inthe package insert. It is not intended to be usedas an assayed quality control material for anyother analyzer system. |
| Number ofAnalytes per via | 1 | 17 |
| Number oflevels per set | 5 | 5 |
| Contents | 5 x 1 mL | 5 x 5 mL |
| Matrix | Human and Bovine Albumin | Human and Bovine Albumin |
| Type of Analytes | T-Uptake | Cortisol, Digoxin, Estradiol, Ferritin, Folate,Free T4, FSH, hCG, LH, Progesterone,Prolactin, Testosterone, Total PSA, Total T3,Total T4, TSH, and Vitamin B12 |
| Form | Liquid | Lyophilized |
| Storage | 2 to 8° CUntil expiration date | 2 to 8° CUntil expiration date |
| Open VialStability | 10 days at 2 to 8° C | 5 days at 2 to 8° |
C. 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
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of two main elements: a circular text element and an abstract symbol. The text element is arranged in a circle and reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The abstract symbol is a stylized representation of a human figure, with three overlapping profiles suggesting a sense of community or interconnectedness.
Food and Drug Administration
10903 New Hampshire Avenue Silver Spring, MD 20993
Aalto Scientific, Ltd. c/o Dessi Lyakov Regulatory Affairs Manager 1959 Kellogg Ave. Carlsbad. CA 92008
JAN 3 1 2012
Re: K112143 Trade/Device Name: Audit® MicroCV™ T-Uptake Calibration/Verification Set Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material Regulatory Class: Class I, reserved Product Code: JJX Dated: January 17, 2012 Received: January 18, 2012
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 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 (OS) 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 predicate device results in a classification for your device and thus, permits your device to proceed to the market.
{4}------------------------------------------------
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/ResourcesforYou/Industry/default.htm
Sincerely yours,
N
Couriney 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}------------------------------------------------
Image /page/5/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 that form the shape of a pine tree. Below the triangular shape, the text "Aalto Scientific, Ltd." is written in a simple, sans-serif font.
510(k) Notification Audit® MicroCV™ T-Uptake Calibration/Verification Set
Indications for Use
510(k) Number: K112143
Device Name: Audit® MicroCV™ T-Uptake Calibration/Verification Set
Indications For Use:
Audit® MicroCV™ T-Uptake Calibration/Verification Set consists of five levels of human and bovine albumin based serum containing T-Uptake. The Audit® MicroCV™ T-Uptake Calibration/Verification Set is a quality control material intended for use in the quantitative verification of calibration and reportable range of the Roche T-uptake Assay when performed on the P-Modular Analyzer 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® MicroCV™ T-Uptake Calibration/Verification 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)
Qus
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K112143
§ 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.