(118 days)
Not Found
No
The device description and intended use clearly describe a liquid stable control material for monitoring assay conditions, with no mention of AI or ML capabilities.
No
The device is described as an assayed control for monitoring assay conditions in clinical laboratory determinations, not for treating patients.
No
This device is described as an "assayed control" material, used for "monitoring assay conditions" and "assuring consistent performance of reagent and instrument," rather than for diagnosing patient conditions.
No
The device description clearly states it is a "liquid stable control material prepared from human serum" and is offered in vials, indicating it is a physical substance, not software.
Based on the provided information, 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 in many clinical laboratory determinations." This is a key function of IVD devices, which are used to examine specimens from the human body to provide information for diagnostic purposes. While this specific device is a control, controls are essential components of IVD testing to ensure the accuracy and reliability of the results.
- Device Description: It's a "liquid stable control material prepared from human serum." This material is used in vitro (outside the body) to assess the performance of diagnostic assays.
- Intended User / Care Setting: It's intended for use in a "clinical laboratory," which is the typical setting for IVD testing.
- Predicate Device: The mention of a predicate device (K981532; Bio-Rad Laboratories Lyphochek Immunoassay Plus Control) which is also a control material used in clinical laboratories, further supports its classification as an IVD. Predicate devices are used to demonstrate substantial equivalence for regulatory purposes, and they are typically devices within the same regulatory classification.
While the device itself is a control and not a test that directly diagnoses a condition, it is an integral part of the in vitro diagnostic process. It's used to ensure the quality and accuracy of the assays that do provide diagnostic information. Therefore, it falls under the umbrella of IVD devices.
N/A
Intended Use / Indications for 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•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.
Product codes
JJY
Device Description
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: OIM-101, Description: Level 1, Size: 6 vials of Level 1, 5 mLs per vial
Catalog Number: OIM-202, Description: Level 2, Size: 6 vials of Level 2, 5 mLs per vial
Catalog Number: OIM-303, Description: Level 3, Size: 6 vials of Level 3, 5 mLs per vial
Catalog Number: OIM-SP, Description: Sample-pack, Size: 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: OPRO-1, Description: Level 1, Size: 6 vials of Level 1, 5 mLs per vial
Catalog Number: OPRO-2, Description: Level 2, Size: 6 vials of Level 2, 5 mLs per vial
Catalog Number: OPRO-3, Description: Level 3, Size: 6 vials of Level 3, 5 mLs per vial
Catalog Number: OPRO-SP, Description: Sample-pack, Size: 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
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
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
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•IMMUNE
MAS® Omni•IMMUNE PRO |
|---------------------------|------------------------------------------------------------------------------|
| Trade/ Proprietary Name | Thermo Scientific MAS® Omni•IMMUNE
Thermo 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
1
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 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 |
2
Comparison of Technological Characteristics
| Comparison
| Device | Subject Device | Predicate |
|---|---|---|
| MAS® Omni•IMMUNE | ||
| MAS® Omni•IMMUNE PRO | Bio-Rad Lyphochek® Immunoassay Plus | |
| Control | ||
| 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 |
| Control | ||
| Levels | Level 1 | |
| Level 2 | ||
| Level 3 | Level 1 | |
| Level 2 | ||
| Level 3 | ||
| Storage | -20°C | 2-8°C |
| Open Vial | ||
| Stability | 30 days (2-8 °C) | 7 days (2-8 °C) except |
- C-Peptide, Folate and PSA (stable for 3 days after reconstitution).
- ACTH, Calcitonin and Gastrin (Should be assayed immediately after reconstitution). |
| Shelf Life | 36 months | 36 months |
| Analytes by
Configuration | 17-alpha-OH Progesterone
25-Hydroxy Vit D
Acetaminophen
ACTH
AFP | 17-alpha-OH Progesterone
25-Hydroxy Vit D
Acetaminophen
ACTH
AFP |
| 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 | |
3
・
ﺑ
4
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.
5
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
6
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
7
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