(118 days)
Thermo Scientific MAS® Omni•IMMUNE is intended for use as an assayed control for monitoring assay conditions in many clinical laboratory determinations. Include OmnirIMMUNE with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument
Thermo Scientific MAS® Omni•IMMUNE PRO is intended for use as an assayed control for monitoring assay conditions in many clinical laboratory determinations. Include Omni•IMMUNE PRO with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.
Omni•IMMUNE is a liquid stable control material prepared from human serum. Analyte levels are adjusted with various pure chemicals and preparations from human tissue or body fluids. Preservatives and stabilizers are added to maintain product integrity.
The control is offered in three levels with the following configuration:
MAS® Omni•IMMUNE
Catalog Number Description Size
OIM-101 Level 1 6 vials of Level 1, 5 mLs per vial
OIM-202 Level 2 6 vials of Level 2, 5 mLs per vial
OIM-303 Level 3 6 vials of Level 3, 5 mLs per vial
OIM-SP Sample-pack 1 vial of Level 1, 5 mLs per vial
1 vial of Level 2, 5 mLs per vial
1 vial of Level 3, 5 mLs per vial
MAS® Omni•IMMUNE PRO
Catalog Number Description Size
OPRO-1 Level 1 6 vials of Level 1, 5 mLs per vial
OPRO-2 Level 2 6 vials of Level 2, 5 mLs per vial
OPRO-3 Level 3 6 vials of Level 3, 5 mLs per vial
OPRO-SP Sample-pack 1 vial of Level 1, 5 mLs per vial
1 vial of Level 2, 5 mLs per vial
1 vial of Level 3, 5 mLs per vial
This document is a 510(k) summary for a Quality Control Material (assayed and unassayed), not an AI medical device. Therefore, many of the requested elements for describing an AI device's acceptance criteria and study are not applicable.
However, I can extract the relevant information from the provided text regarding the device's performance and the study demonstrating its equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device (quality control material), the "acceptance criteria" relate to demonstrating substantial equivalence to a predicate device, primarily through comparable design, intended use, and performance characteristics in the context of quality control. The "reported device performance" focuses on the stability and matrix properties of the control material, and its ability to function as intended across various analytes.
| Criterion Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Intended Use | Comparable to predicate device: "assayed control for monitoring assay conditions... compare observations with expected ranges" | Identical: "intended for use as an assayed control for monitoring assay conditions in many clinical laboratory determinations. ... The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument." |
| Matrix | Human Serum | Human Serum |
| Form | Effectively serves as a control material, regardless of physical form. (Predicate: Lyophilized) | Frozen Liquid (Note: This is a difference but the submission argues it does not raise new questions of safety or efficacy and is therefore still substantially equivalent.) |
| Control Levels | Three levels (1, 2, 3) | Three levels (1, 2, 3) |
| Shelf Life | Comparable shelf life for stability. (Predicate: 36 months) | 36 months |
| Open Vial Stability | Comparable open vial stability for practical use. (Predicate: 7 days, with some analytes shorter) | 30 days (2-8 °C). (Note: This is an improvement over the predicate, further supporting equivalence and potentially enhanced utility.) |
| Analytes | Capable of monitoring performance for a broad range of relevant analytes. | Extensive list of analytes provided, largely overlapping with the predicate, and including additional analytes, demonstrating broad applicability. Implicitly, laboratory performance data (not detailed in this summary but part of the full 510(k) submission) would have shown the control material provides accurate target values and ranges for each analyte. |
| Overall Performance | Functions as intended, demonstrating substantial equivalence to the predicate device in safety and effectiveness for its intended use. | "Substantial equivalence has been demonstrated through performance testing to verify that the device functions as intended and that design specifications have been satisfied." |
The following points are largely not applicable as the device is a quality control material, not an AI device. I will address them with "N/A" and briefly explain why if appropriate.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- N/A. This is a quality control material, not an AI algorithm processing diagnostic images or patient data. The "test set" would primarily involve internal laboratory validation of the control material's stability, homogeneity, and assigned values across various assay systems, rather than a dataset of patient samples in the traditional sense of an AI study. The data provenance would be internal laboratory testing data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- N/A. Ground truth for a quality control material involves establishing precise target values and acceptable ranges for analytes. This is done through extensive analytical testing, calibration, and statistical analysis by qualified laboratory scientists and chemists, not "experts" in the clinical diagnostic sense of interpreting patient results.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- N/A. Adjudication methods like 2+1 or 3+1 are used in clinical studies where expert consensus is needed to establish a "true" diagnosis or finding for a given patient case, often in the context of medical imaging interpretation. This is not relevant for the technical validation of a laboratory quality control material.
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
- N/A. This device is a quality control material for laboratory assays, not an AI-powered diagnostic tool, and therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- N/A. This device is a consumable laboratory reagent, not an algorithm. Its "performance" is inherent in its chemical composition and stability characteristics, which allow it to provide known concentrations of analytes for quality control purposes.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For a quality control material, the "ground truth" (i.e., the assigned values and acceptable ranges for each analyte) are established through:
- Reference Methods: Using highly accurate and precise reference methods to determine the true concentration of each analyte in the control material.
- Inter-laboratory Consensus: Often involving assays on multiple high-performing instruments across different laboratories to ensure robustness and generalizability of the assigned values.
- Traceability: Ensuring traceability to recognized international standards (where available) for the analytes.
8. The sample size for the training set
- N/A. This device is not an AI algorithm and does not have a "training set."
9. How the ground truth for the training set was established
- N/A. As there is no training set for an AI algorithm, this question is not applicable.
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510K SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of Safe Medical Devices Act of 1990 and 21 CFR 807.92
The assigned 510(k) number is: K110616
Company/Contact person
Lisa Charter Manager, Regulatory Affairs Microgenics Corporation Thermo Fisher Scientific, Clinical Diagnostics Division 46360 Fremont Blvd. Fremont, CA 94538 (510) 979-5142 Office (510) 979-5422 Fax Lisa.Charter@thermofisher.com
Date Prepared
June 20, 2011
Requlatory Declarations
| Common / Usual Name | MAS® Omni•IMMUNEMAS® Omni•IMMUNE PRO |
|---|---|
| Trade/ Proprietary Name | Thermo Scientific MAS® Omni•IMMUNEThermo Scientific MAS® Omni•IMMUNE PRO |
| Classification Regulation | 21 CFR 862.1660 |
| Device Class | Class I |
| Device Regulation Panel | Clinical Chemistry |
| Product Code | JJY |
Intended use
Thermo Scientific MAS® Omni•IMMUNE is intended for use as an assayed control for monitoring assay conditions in many clinical laboratory determinations. Include OmnirIMMUNE with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument
Thermo Scientific MAS® Omni+MMUNE PRO is intended for use as an assayed control for monitoring assay conditions in many clinical laboratory determinations. Include Omni+IMMUNE PRO with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.
Legally marketed device to which equivalency is claimed
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Thermo Scientific MAS Omni•IMMUNE Control is substantially equivalent to the previously cleared Bio-Rad Laboratories Lyphochek Immunoassay Plus Control (K981532).
Description of Device
Omni•IMMUNE is a liquid stable control material prepared from human serum. Analyte levels are adjusted with various pure chemicals and preparations from human tissue or body fluids. Preservatives and stabilizers are added to maintain product integrity.
The control is offered in three levels with the following configuration:
| MAS® Omni•IMMUNE | ||
|---|---|---|
| Catalog Number | Description | Size |
| OIM-101 | Level 1 | 6 vials of Level 1, 5 mLs per vial |
| OIM-202 | Level 2 | 6 vials of Level 2, 5 mLs per vial |
| OIM-303 | Level 3 | 6 vials of Level 3, 5 mLs per vial |
| OIM-SP | Sample-pack | 1 vial of Level 1, 5 mLs per vial1 vial of Level 2, 5 mLs per vial1 vial of Level 3, 5 mLs per vial |
| MAS® Omni•IMMUNE PRO | ||
| Catalog Number | Description | Size |
| OPRO-1 | Level 1 | 6 vials of Level 1, 5 mLs per vial |
| OPRO-2 | Level 2 | 6 vials of Level 2, 5 mLs per vial |
| OPRO-3 | Level 3 | 6 vials of Level 3, 5 mLs per vial |
| OPRO-SP | Sample-pack | 1 vial of Level 1, 5 mLs per vial1 vial of Level 2, 5 mLs per vial1 vial of Level 3, 5 mLs per vial |
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Comparison of Technological Characteristics
| ComparisonDevice | Subject Device | Predicate |
|---|---|---|
| MAS® Omni•IMMUNEMAS® Omni•IMMUNE PRO | Bio-Rad Lyphochek® Immunoassay PlusControl | |
| 510(k)number | K110616 | K981532 |
| Intended Use | Thermo Scientific MAS® Omni•IMMUNE is intended for use as an assayed control for monitoring assay conditions in many clinical laboratory determinations. Include Omni•IMMUNE with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.Thermo Scientific MAS® Omni•IMMUNE PRO is intended for use as an assayed control for monitoring assay conditions in many clinical laboratory determinations. Include Omni•IMMUNE PRO with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument. | Lyphochek Immunoassay Plus Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. |
| Matrix | Human Serum | Human Serum |
| Form | Frozen Liquid | Lyophilized |
| ControlLevels | Level 1Level 2Level 3 | Level 1Level 2Level 3 |
| Storage | -20°C | 2-8°C |
| Open VialStability | 30 days (2-8 °C) | 7 days (2-8 °C) except1. C-Peptide, Folate and PSA (stable for 3 days after reconstitution).2. ACTH, Calcitonin and Gastrin (Should be assayed immediately after reconstitution). |
| Shelf Life | 36 months | 36 months |
| Analytes byConfiguration | 17-alpha-OH Progesterone25-Hydroxy Vit DAcetaminophenACTHAFP | 17-alpha-OH Progesterone25-Hydroxy Vit DAcetaminophenACTHAFP |
| Aldosterone | Aldosterone | |
| Amikacin | Amikacin | |
| Anti-Tg (PRO Version Only) | Anti-Tg | |
| Anti-TPO (PRO Version Only) | Anti-TPO | |
| Benzodiazepine | - | |
| Beta-2-Microglobulin | - | |
| CA 125 | - | |
| CA 15-3 | - | |
| CA 19-9 | - | |
| β-hCG | Calcitonin | |
| Carbamazepine | β-hCG | |
| CEA | Carbamazepine | |
| CK-MB (MMB) | CEA | |
| Cortisol | - | |
| C-Peptide | Cortisol | |
| DHEA-Sulfate | C-Peptide | |
| Digoxin | DHEA-Sulfate | |
| Disopyramide | Digoxin | |
| Estradiol | Disopyramide | |
| Estriol free | Estradiol | |
| Ethosuximide | Estriol free | |
| Ferritin | Ethosuximide | |
| Folate | Ferritin | |
| Fructosamine | Folate | |
| FSH | Fructosamine | |
| Gastrin | FSH | |
| Gentamicin | Gastrin | |
| Growth Hormone | Gentamicin | |
| hCG | Growth Hormone | |
| Homocysteine | hCG | |
| IgE | - | |
| IGF-1 | IgE | |
| Inhibin A | - | |
| Insulin | - | |
| LH | Insulin | |
| Lidocaine | LH | |
| Lithium | Lidocaine | |
| NAPA | Lithium | |
| PAP | NAPA | |
| Phenobarbital | - | |
| Phenytoin | PAP | |
| Phenytoin, Free | - | |
| Primidone | Phenobarbital | |
| Procainamide | Phenytoin | |
| Procalcitonin | Phenytoin, Free | |
| Progesterone | Primidone | |
| Prolactin | Procainamide | |
| PSA | - | |
| Free PSA | Progesterone | |
| PTH, Intact | Prolactin | |
| Quinidine | PSA | |
| Salicylate | Free PSA | |
| SHBG (PRO Version Only) | PTH, Intact | |
| TBG | Quinidine | |
| T3 | Salicylate | |
| Free T3 | SHBG | |
| T4 | TBG | |
| Free T4 | T3 | |
| Testosterone | Free T3 | |
| Theophylline | T4 | |
| Thyroglobulin | Free T4 | |
| Tobramycin | Testosterone | |
| Tri-Cyclic Antidepressants | Theophylline | |
| TSH | Thyroglobulin | |
| T-Uptake | Tobramycin | |
| Valproic Acid | Tri-Cyclic Antidepressants | |
| Valproic Acid, Free | TSH | |
| Vancomycin | T-Uptake | |
| Vitamin B12 | Valproic Acid | |
| Valproic Acid, Free | ||
| Vancomycin | ||
| Vitamin B12 |
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Conclusion
As summarized, the Omni•IMMUNE Control is substantially equivalent to the previously cleared Bio-Rad Lyphochek® Immunoassay Plus Control (K981532). Substantial equivalence has been demonstrated through performance testing to verify that the device functions as intended and that design specifications have been satisfied.
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Image /page/5/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a simple, line-based design.
Microgenics Corporation Thermo Fisher Scientific Clinical Diagnostic Division c/o Ms. Lisa Charter Manager, Regulatory Affairs 46360 Fremont Blvd. Fremont, CA 94538
Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
JUN 29 2011
Re: K110616
Trade Name: Thermo Scientific MAS Omni-Immune, Thermo Scientific MAS Omni-Immune Pro Regulation Number: 21 CFR §862.1660 Regulation Name: Quality Control Material (assayed and unassayed) Regulatory Class: Class I, reserved Product Codes: JJY Dated: May 19, 2011 Received: May 23, 2011
Dear Ms. Charter:
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
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If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Viro 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 no (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
G.C.
Courmey Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
: 4:02 :
Enclosure
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Indication for Use
510(k) Number (if known): K110616
Device Name: Thermo Scientific MAS® Omni•IMMUNE Thermo Scientific MAS® Omni•IMMUNE PRO
Indication for Use:
Thermo Scientific MAS® Omni•MMUNE is intended for use as an assayed control for monitoring assay conditions in many clinical laboratory determinations. Include OmnirIMMUNE with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument
Thermo Scientific MAS® Omni•IMMUNE PRO is intended for use as an assayed control for monitoring assay conditions in many clinical laboratory determinations. Include Omni•IMMUNE PRO with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.
Prescription Use × (21 CFR Part 801 Subpart D) Over the Counter Use
(21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
And/Or
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K110616
§ 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.