(189 days)
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No
The document describes a calibration and verification set for a laboratory assay, which is a quality control material. There is no mention of any computational algorithms, data analysis, or decision-making processes that would involve AI or ML. The device's function is to provide known concentrations for instrument calibration and verification.
No
The device is a quality control material for in vitro diagnostic use, intended to verify the calibration and reportable range of an assay, not to treat or diagnose patients directly.
No
Explanation: This device is a quality control material used for calibration and verification of a T-Uptake assay, not for diagnosing patient conditions, but for ensuring the accuracy of other assays.
No
The device is a physical calibration/verification set consisting of liquid quality control material, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The document explicitly states:
- "The Audit® MicroCV™ T-Uptake Calibration/Verification is for In Vitro Diagnostic use only." in the Intended Use section.
- "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" in the Intended Use section, indicating it is used in a laboratory setting to assess the performance of a diagnostic assay.
- "The Audit® MicroCV™ T-Uptake Calibration/Verification is a human and bovine albumin based, liquid set of QC material." in the Device Description, describing a material used for quality control in diagnostic testing.
These points clearly indicate that the device is intended for use in vitro (outside the body) for diagnostic purposes (specifically, for verifying the performance of a T-uptake assay).
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
JJX
Device Description
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.
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 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.
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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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
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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.
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510(k) Notification Audit® MicroCV™ T-Uptake Calibration/Verification Set
B. Technical Characteristics Compared to Predicate Device
| Characteristics | Audit® MicroCV™ T-Uptake
Calibration/Verification Set
(K112143) | Audit™ MicroCV™ Immunoassay
Linearity Set
(K062668) |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 only as guides. The Audit®
MicroCV™ T-Uptake Calibration/Verification is
for In Vitro Diagnostic use only. | The Audit® MicroCV™ Immunoassay Linearity
consist of five levels of human and bovine
serum albumin matrix. Each level contains the
following analytes: Cortisol, Digoxin, Estradiol,
Ferritin, Folate, Free T4, FSH, hCG, LH,
Progesterone, Prolactin, Testosterone, Total
PSA, Total T3, Total T4,TSH, and Vitamin B12.
These five levels demonstrate a linear
relationship to each other for their respective
analytes, reagents, and instruments.
This product may be used for proficiency testing
in interlaboratory surveys and to perform CLIA
directed calibration verification for these same
analytes 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 system. |
| Number of
Analytes per via | 1 | 17 |
| Number of
levels 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° C
Until expiration date | 2 to 8° C
Until expiration date |
| Open Vial
Stability | 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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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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.
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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
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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