(31 days)
Not Found
No
The device is a control serum used for monitoring assay conditions, not a diagnostic or analytical device that would typically incorporate AI/ML for data processing or interpretation. The description focuses on the composition, storage, and performance testing related to stability and value assignment, with no mention of AI or ML technologies.
No
The device is described as an assayed control serum for monitoring assay conditions related to cardiac and associated critical marker determinations, not for treating a condition or disease.
No
This device is described as an "assayed control serum for monitoring assay conditions related to cardiac and associated critical marker determinations." It is designed to evaluate the performance of diagnostic assays, rather than directly diagnose a patient's condition.
No
The device is a control serum, which is a physical substance used in laboratory testing, not a software application.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "monitoring assay conditions related to cardiac and associated critical marker determinations" in a "clinical laboratory." This clearly indicates its use in a laboratory setting to analyze biological samples (serum in this case) for diagnostic purposes.
- Device Description: The device is a "control serum" containing various analytes relevant to cardiac and critical marker testing. Control materials are a fundamental component of IVD testing, used to verify the accuracy and precision of diagnostic assays.
- Predicate Devices: The mention of predicate devices (K040880 MAS® Cardiolmmune TL and K061196 MAS® Cardiolmmune XL) which are also IVD controls, further supports its classification as an IVD.
- Performance Studies: The performance studies described (shelf life, open/closed vial stability, value assignment) are typical studies conducted for IVD control materials to demonstrate their suitability for use in diagnostic testing.
Therefore, based on the provided information, the Thermo Scientific MAS® Omni•CARDIO™ is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Thermo Scientific MAS® Omni•CARDIO™ is intended for use in the clinical laboratory as an assayed control serum for monitoring assay conditions related to cardiac and associated critical marker determinations.
Product codes (comma separated list FDA assigned to the subject device)
JJY
Device Description
Each MAS® Omni•CARDIO control kit is packaged in a plastic clamshell container with a product insert and value sheet. Each vial contains 3 mL of the control level in an amber glass bottle with black sterile caps. Kits are stored frozen at -20°C. MAS® Omni CARDIO control levels are provided in liquid form and are to be stored at -20°C until the expiration date on the label. The control levels are prepared from human serum and contain the following constituents: Beta-Human Chorionic Gonadotropin (ß-HCG), B-Type Natriuretic Peptide (BNP), Creatine Kinase-MB (CK-MB), D-Dimer, Digitoxin, Homocysteine, High Sensitivity C-Reactive Protein (hsCRP), Human Chorionic Gonadotropin (HCG), Myeloperoxidase (MPO), Myoglobin, N-Terminal Prohormone of Brain Natriuretic Peptide (NTproBNP), Procalcitonin (PCT), Total Creatine Kinase (CK), Troponin I, Troponin T.
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
clinical 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Stability Testing and Value Assignment Summary: Accelerated testing was carried out for the evaluation lots at three elevated temperatures in order to support a shelf life storage temperature of -20°C for 36 months. For each temperature tested, the required number of days of stress without failure was determined that would be equivalent to 36 months storage at -20°C. All analytes and lots tested met the minimum number of days for all temperatures tested in support of a shelf life claim of 36 months frozen at -20℃. Real time testing at -20°C is on-going. Open and closed vial testing was carried out at 5°C for all claimed analytes on the evaluation lots. Vials were thawed, mixed, and placed at 2-8°C for the study. Vials were opened briefly each work day (open vial) or remained unopened (closed vial) until time of assay. Multiple timepoints were tested and the point of failure determined by linear regression analysis of the data. All analytes met the required claim of 15 days storage for both open and closed vial testing with the exception of Myoglobin and NT-ProBNP (10 days) and Homocysteine (5 days). Value assignment testing was carried out to determine typical values that would be seen for the product across different analyzer platforms. Evaluation lots were sent to multiple sites, typically 2 or 3 lots per instrument platform, and assaved over 5 days in duplicate. For each analyte and analyzer combination, the data was averaged to determine a grand mean. Value assignment ranges were established at +/-20% around the grand mean and were expanded if needed to ensure the minimum and maximum values in the data set were within the established range. Values for the evaluation lots all fell within the established ranges.
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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Omni Cardio 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K122291
Company / Contact Person
Karen Lee Regulatory Affairs Specialist Thermo Fisher Scientific, Clinical Diagnostics Division 46360 Fremont Blvd. Fremont, CA 94538 Phone: (510) 979-5000 x31814 Fax: (510) 979-5422 E-mail: karen.lee@thermofisher.com
Date Prepared
August 29, 2012
Regulatory Declarations
| Common / Usual Name | MAS® Omni•CARDIO |
|---|---|
| Trade / Proprietary Name | Thermo Scientific MAS® Omni•CARDIO |
| Classification Regulation | 21 CFR 862.1660 |
| Device Class | Class I, Reserved |
| Device Regulation Panel | Clinical Chemistry |
| Product Code | JJY |
Intended Use MAS® Omni•CARDIO
Thermo Scientific MAS® Omni•CARDIO™ is intended for use in the clinical laboratory as an assayed control serum for monitoring assay conditions related to cardiac and associated critical marker determinations.
Legally Marketed Device to Which Equivalency is Claimed
The Thermo Scientific MAS® Omni+CARDIO is substantially equivalent to the previously cleared MAS® Cardiolmmune TL (K040880) and MAS® Cardiolmmune XL (K061196).
Device Description
Each MAS® Omni•CARDIO control kit is packaged in a plastic clamshell container with a product insert and value sheet. Each vial contains 3 mL of the control level in an amber glass bottle with black sterile caps. Kits are stored frozen at -20°C.
1
Below are the different kit configurations:
| Kit | Configuration |
|---|---|
| Level UL | 6 x 3 mL |
| Level L | 6 x 3 mL |
| Level 1 | 6 x 3 mL |
| Level 2 | 6 x 3 mL |
| Level 3 | 6 x 3 mL |
| Multi-Pack | Level 1 – 2 x 3 mL |
| Level 2 – 2 x 3 mL | |
| Level 3 – 2 x 3 mL | |
| Sample Pack | Level UL – 1 x 3 mL |
| Level L – 1 x 3 mL | |
| Level 1 – 1 x 3 mL | |
| Level 2 – 1 x 3 mL | |
| Level 3 – 1 x 3 mL |
MAS® Omni CARDIO control levels are provided in liquid form and are to be stored at -20°C until the expiration date on the label. The control levels are prepared from human serum and contain the following constituents: Beta-Human Chorionic Gonadotropin (ß-HCG), B-Type Natriuretic Peptide (BNP), Creatine Kinase-MB (CK-MB), D-Dimer, Digitoxin, Homocysteine, High Sensitivity C-Reactive Protein (hsCRP), Human Chorionic Gonadotropin (HCG), Myeloperoxidase (MPO), Myoglobin, N-Terminal Prohormone of Brain Natriuretic Peptide (NTproBNP), Procalcitonin (PCT), Total Creatine Kinase (CK), Troponin I, Troponin T.
Stability Testing and Value Assignment Summary:
Accelerated testing was carried out for the evaluation lots at three elevated temperatures in order to support a shelf life storage temperature of -20°C for 36 months. For each temperature tested, the required number of days of stress without failure was determined that would be equivalent to 36 months storage at -20°C. All analytes and lots tested met the minimum number of days for all temperatures tested in support of a shelf life claim of 36 months frozen at -20℃. Real time testing at -20°C is on-going.
Open and closed vial testing was carried out at 5°C for all claimed analytes on the evaluation lots. Vials were thawed, mixed, and placed at 2-8°C for the study. Vials were opened briefly each work day (open vial) or remained unopened (closed vial) until time of assav. Multiple timepoints were tested and the point of failure determined by linear regression analysis of the data. All analytes met the required claim of 15 days storage for both open and closed vial testing with the exception of Myoglobin and NT-ProBNP (10 days) and Homocysteine (5 days).
Value assignment testing was carried out to determine typical values that would be seen for the product across different analyzer platforms. Evaluation lots were sent to multiple sites, typically 2 or 3 lots per instrument platform, and assaved over 5 days in duplicate. For each analyte and analyzer combination, the data was averaged to determine a grand mean. Value assignment ranges were established at +/-20% around the grand mean and were expanded if needed to
2
ensure the minimum and maximum values in the data set were within the established range. Values for the evaluation lots all fell within the established ranges.
| Analyte | Units | Level UL | Level L | Level 1 | Level 2 | Level 3 |
|---|---|---|---|---|---|---|
| BNP 32 | pg/mL | 56 | 104 | 216 | 640 | 2600 |
| CK-MB | ng/mL | 1.7 | 4.3 | 6.5 | 32.5 | 100 |
| D-Dimer | ng/mL | Not Claimed | Not Claimed | 400 | 1300 | 3900 |
| Digitoxin | ng/mL | 3.9 | 8.1 | 13.5 | 29.0 | 62 |
| Homocysteine | μmol/L | Not Claimed | Not Claimed | 6.5 | 12.0 | 31.0 |
| hsCRP | mg/L | 0.20 | 0.80 | 3.20 | 6.5 | 13.0 |
| Myeloperoxidase | ||||||
| (MPO) | pmol/L | 20 | 46 | 330 | 1040 | 4550 |
| Myoglobin | ng/mL | 11.0 | 29.0 | 57 | 310 | 750 |
| NT-proBNP | pg/mL | 45 | 125 | 620 | 3100 | 15600 |
| Procalcitonin | ng/mL | 0.18 | 0.32 | 0.65 | 3.90 | 15.6 |
| β-HCG | mIU/mL | Not Claimed | Not Claimed | 12.0 | 35 | 270 |
| Total CK | IU/L | 42 | 78 | 169 | 400 | 780 |
| Troponin I (Tnl) | ng/mL | 0.025 | 0.080 | 0.45 | 1.50 | 20.0 |
| Troponin T (TnT) | pg/mL | 10 | 30 | 200 | 750 | 7800 |
:
Omni Cardio – Target Ranges
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Comparison of Technological Characteristics
| Comparison | Proposed Device | Predicate1 | Predicate 2 |
|---|---|---|---|
| Proprietary Name | Thermo Scientific MAS® | ||
| Omni•CARDIO | MAS® Cardiolmmune TL | MAS® Cardiolmmune XL | |
| 510k Number | K122291 | K040880 | K061196 |
| Intended Use | Thermo Scientific MAS® | ||
| Omni•CARDIO™ is intended | |||
| for use in the clinical | |||
| laboratory as an assayed | |||
| control serum for monitoring | |||
| assay conditions related to | |||
| cardiac and associated | |||
| critical marker | |||
| determinations. | Cardiolmmune® TL is | ||
| intended for use in the | |||
| clinical laboratory as an | |||
| assayed control serum | |||
| suitable for monitoring assay | |||
| conditions in specific cardiac | |||
| marker determinations. | MAS® Cardiolmmune® XL is | ||
| intended for use in the | |||
| clinical laboratory as an | |||
| assayed control serum for | |||
| monitoring assay conditions | |||
| in specific cardiac marker | |||
| determinations. | |||
| Matrix | Human Serum | Human Serum | Human Serum |
| Format | Frozen Liquid | Frozen Liquid | Frozen Liquid |
| Control Levels | 5 | 4 | 4 |
| Storage | -20°C | -20°C | -20°C |
| Shelf Life | 36 months | 36 months | 36 months |
| Open Vial Stability | 15 days (2-8°C) except | ||
| NT-ProBNP, Myoglobin (10 | |||
| days) | |||
| Homocysteine (5 days) | 30 days (2-8°C) except | ||
| NT-ProBNP (10 days) | 30 days (2-8°C) except | ||
| CK-MB, Troponin-T, BNP | |||
| 32, NT-ProBNP (15 days) | |||
| Myoglobin (5 days) | |||
| Closed Vial Stability | 15 days (2-8°C) except | ||
| ProBNP, Myoglobin (10 | |||
| days) | |||
| Homocysteine (5 days) | 30 days (2-8°C) | N/A | |
| Analytes | BNP 32 | ||
| CK-MB | |||
| D-Dimer | |||
| Digitoxin | |||
| Homocysteine | |||
| hsCRP | |||
| Myeloperoxidase (MPO) | |||
| Myoglobin | |||
| NT-ProBNP | |||
| Procalcitonin (PCT) | |||
| bHCG | |||
| Total CK | |||
| Troponin-I (Tnl) | |||
| Troponin-T (TnT) | CK-MB | ||
| Digitoxin | |||
| hsCRP | |||
| Myoglobin | |||
| NT-ProBNP | |||
| Troponin-l (Tnl) | |||
| Troponin-T (TnT) | BNP 32 | ||
| CK-MB | |||
| Digitoxin | |||
| Homocysteine | |||
| hsCRP | |||
| Myoglobin | |||
| NT-ProBNP | |||
| Troponin-I (Tnl) | |||
| Troponin-T (TnT) |
Conclusion
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/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 seal is an abstract image of an eagle or bird-like figure.
10903 New Hampshire Avenue Silver Spring, MD 20993
Microgenics Corporation Thermo Fisher Scientific, Clinical Diagnostics Division c/o Karen Lee 46360 Fremont Blvd. Fremont, CA 94538
AUG 3 1 2012
Re: K122291
Trade Name: MAS® Omni·CARDIO Regulation Number: 21 CFR 8862.1660 Regulation Name: Ouality Control Material (assayed and unassayed) Regulatory Class: Class I, reserved Product Codes: JJY Dated: July 30, 2012 Received: July 31, 2012
Dear Ms. Lee:
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).
5
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 PICER 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 Tou may 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 vours,
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
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Indications for Use Statement
510(k) Number (if known) K122291
Device Name MAS® Omni · CARDIO
Indications For Use MAS® Omni•CARDIO
Thermo Scientific MAS® OmnivCARDIO™ is intended for use in the clinical laboratory as an assayed control serum for monitoring assay conditions related to cardiac and associated critical marker determinations.
Prescription Use
X
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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 Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
K12229 510(k)
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