(231 days)
No
The document describes a quality control material for laboratory assays and does not mention any AI or ML components.
No
The device is described as an assayed control for monitoring assay conditions in clinical laboratory determinations, not for treating any medical condition.
No
Explanation: The device is described as an "assayed control for monitoring assay conditions" and is used to "assure consistent performance of reagent and instrument." It is not used to diagnose a patient's medical condition.
No
The device description clearly states it is a "liquid stable control material prepared from human serum," indicating it is a physical substance, not software.
Yes, based on the provided information, the Thermo Scientific MAS® Omni•CORE™ device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "monitoring assay conditions in many clinical laboratory determinations" and to be included "with patient serum specimens when assaying for any of the constituents." This indicates it's used in vitro (outside the body) to assess the performance of diagnostic tests.
- Device Description: The description details its composition as a "liquid stable control material prepared from human serum" with added analytes and preservatives. This is consistent with the nature of IVD control materials.
- Predicate Devices: The listed predicate devices (MAS® Chem-TRAK H and MAS® Immunology Controls) are also IVD control materials, further supporting the classification of Omni•CORE as an IVD.
Control materials like Omni•CORE are essential components of the IVD process, used to ensure the accuracy and reliability of diagnostic tests performed on patient samples.
N/A
Intended Use / Indications for Use
Thermo Scientific MAS® Omni•CORE™ is intended for use as an assayed control for monitoring assay conditions in many clinical laboratory determinations. Include MAS® Omni•CORE with patient serum specimens when assaying for any of the constituents. Assay values are provided for the specific systems listed. The user can compare observations with their expected ranges as a means of assuring consistent performance of reagent and instrument.
Product codes
JJY
Device Description
Omni•CORE is a liquid stable control material prepared from human serum. Analyte levels are adjusted with various animal extracts and non-protein materials including drugs, drug metabolites and purified chemicals. Amylase, ALT/GPT, CK and Lipase are obtained from porcine tissue; alkaline phosphatase and GGT are from bovine tissue; LDH is from avian tissue. Preservatives and stabilizers are added to maintain product integrity.
The control is offered in three levels with the following configuration:
| MAS® Omni-CORE | ||
|---|---|---|
| Catalog Number | Description | Size |
| OCORE-101 | Level 1 | 6 vials of Level 1, 5 mLs per vial |
| OCORE-202 | Level 2 | 6 vials of Level 2, 5 mLs per vial |
| OCORE-303 | Level 3 | 6 vials of Level 3, 5 mLs per vial |
| OCORE-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 |
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)
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.
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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: K110738
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
October 31, 2011
Regulatory Declarations
| Common / Usual Name | MAS® Omni•CORE |
|---|---|
| Trade/ Proprietary Name | Thermo Scientific MAS® Omni•CORE |
| Classification Regulation | 21 CFR 862.1660 – Quality control material (assayed and unassayed) |
| Device Class | Class I |
| Device Regulation Panel | Clinical Chemistry |
| Product Code | JJY |
Intended use
Thermo Scientific MAS® Omni•CORE™ is intended for use as an assayed control for monitoring assay conditions in many clinical laboratory determinations. Include MAS® Omni•CORE with patient serum specimens when assaying for any of the constituents. Assay values are provided for the specific systems listed. The user can compare observations with their expected ranges as a means of assuring consistent performance of reagent and instrument.
Legally marketed device to which equivalency is claimed
MAS® Omni•CORE is substantially equivalent to the previously cleared MAS® Chem-TRAK H (K092051) and MAS® Immunology (K960824) Controls.
Fremont, CA
94538-6406
1
Description of Device
Omni•CORE is a liquid stable control material prepared from human serum. Analyte levels are adjusted with various animal extracts and non-protein materials including drugs, drug metabolites and purified chemicals. Amylase, ALT/GPT, CK and Lipase are obtained from porcine tissue; alkaline phosphatase and GGT are from bovine tissue; LDH is from avian tissue. Preservatives and stabilizers are added to maintain product integrity.
The control is offered in three levels with the following configuration:
| MAS® Omni-CORE | ||
|---|---|---|
| Catalog Number | Description | Size |
| OCORE-101 | Level 1 | 6 vials of Level 1, 5 mLs per vial |
| OCORE-202 | Level 2 | 6 vials of Level 2, 5 mLs per vial |
| OCORE-303 | Level 3 | 6 vials of Level 3, 5 mLs per vial |
| OCORE-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 |
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Comparison of Technological Characteristic
| Comparison | Subject Device | Predicate 1 | Predicate 2 |
|---|---|---|---|
| Device | MAS® Omni-CORE | MAS® ChemTRAK H | MAS® Immunology Control |
| 510(k) number | K110738 | K092051 | K960824 |
| Intended Use | Thermo Scientific MAS® Omni-CORETM is | ||
| intended for use as an assayed control for | |||
| monitoring assay conditions in many clinical | |||
| laboratory determinations. Include MAS® | |||
| Omni-CORE with patient serum specimens | |||
| when assaying for any of the constituents. | |||
| Assay values are provided for the specific | |||
| systems listed. The user can compare | |||
| observations with their expected ranges as a | |||
| means of assuring consistent performance of | |||
| reagent and instrument. | chemTRAK® H is intended for use as a | ||
| consistent test sample of known concentration | |||
| for monitoring assay conditions in many clinical | |||
| laboratory determinations. Include chemTRAK® | |||
| H with patient serum specimens when assaying | |||
| for any of the listed constituents. The user can | |||
| compare observations with expected ranges as | |||
| a means of assuring consistent performance of | |||
| reagent and instrument. |
Moni-Trol® H is intended for use as a consistent
test sample of known concentration for
monitoring assay conditions in many clinical
laboratory determinations. Include Moni-Trol® H
with patient serum specimens when assaying
for any of the listed constituents. The user can
compare observations with expected ranges as
a means of assuring consistent performance of
reagent and instrument. | Immunology Control is intended for use in
the clinical laboratory as a consistent test
sample of known concentration for-
monitoring assay conditions in many
immunological determinations. Include
Immunology control with patient serum
specimens when assaying for any of the
listed constituents. The user can compare
observations with expected ranges as a
means of assuring consistent performance of
reagent and instrument. |
| Matrix | Human Serum | Human Serum | Human Serum |
| Form | Frozen Liquid | Frozen Liquid | Liquid |
| Control Levels | Level 1
Level 2
Level 3 | Level 1
Level 2
Level 3 | Level 1
Level 2
Level 3 |
| Storage | -20°C | -20°C | 2-8°C |
| Shelf Life | 3 years | 2.5 year | 2 years |
| Analytes by
Configuration | Acetaminophen
Albumin
ALK Phos. (Alkaline Phosphatase)
alpha-1-Acid Glycoprotein
alpha-1-Antitrypsin
alpha-2-Macroglobulin
ALT | Acetaminophen
Acid Phosphatase*
Albumin
Alkaline Phosphatase, ALP
Alanine Aminotransferase, ALT
Alpha-Fetoprotein, AFP*
Amikacin | Albumin
alpha-1-Acid Glycoprotein
alpha-1-Antitrypsin
alpha-2-Macroglobulin
Antistreptolysin
Antithrombin III
Apolipoprotein A |
ww.thermofisher.com
www.microgenics.com 510-979-5000
510-979-5002 fax
46360 Fremont Blvd
Fremont, CA
94538-6406
Diagnostics Division
Microgenics Products
4
3
| ThermoFisher |
|---|
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| Amikacin | Amylase | Apolipoprotein B |
|---|---|---|
| Amylase | Apolipoprotein A (APO A) | Beta 2 Microglobulin |
| Antistreptolysin O (ASO) | Apolipoprotein B (APO B) | C3 Complement |
| Apolipoprotein A1 | Aspartate Aminotransferase, AST | C4 Complement |
| Apolipoprotein B | Bilirubin, Direct | Ceruloplasmin |
| AST | Bilirubin, Total | C-Reactive Protein |
| Beta 2 Microglobulin | Blood Urea Nitrogen, BUN | Haptoglobin |
| Bile Acids | C3 Complement* | Immunoglobulin A |
| Bilirubin, Direct (DBIL) | C4 Complement* | Immunoglobulin E |
| Bilirubin, Total (BILT) | Caffeine | Immunoglobulin G |
| BUN | Calcium | Immunoglobulin M |
| C3 Complement | Carbamazepine | Kappa Light Chain |
| C4 Complement | Chloride | Lamda Light Cha |
| Caffeine | Cholesterol | Prealbumin |
| Calcium | Creatine Kinase, CK | Properidin Factor B |
| Carbamazepine | CO2 | Rheumatoid Factor |
| Ceruloplasmin | C-Reactive Protein, CRP* | Total Protein |
| Chloride | Creatinine | Transferrin |
| Cholesterol | Digoxin | |
| CK | Disopyramide | |
| CO2 | Ethanol | |
| Copper | Ethosuximide | |
| Cortisol | Ferritin* | |
| C-Reactive Protein (CRP) | Gentamicin | |
| Creatinine | Gamma Glutamyltransferase, GGT | |
| Digoxin | Glucose | |
| Disoprymide | Glutamate Dehydrogenase, GLDH* | |
| Ethanol | Haptoglobin* | |
| Ethosuximide | Hydroxybutyrate Dehydrogenase, HBDH* | |
| Ferritin | High Density Lipoprotein Cholesterol, HDL | |
| Gentamicin | Human Chorionic Gonadotrophin, hCG* | |
| GGT | Immunoglobulin A, IgA* | |
| Glucose | Immunoglobulin G, IgG* | |
| Haptoglobin | Immunoglobulin M, IgM* | |
| HDL Cholesterol | Iron | |
| IgA | Iron Binding Capacity, Total | |
| IgE | Lactic Acid | |
| IgG | LDH | |
| IgM | LDL-Cholesterol | |
| Iron | Lidocaine |
Diagnostics Division
Microgenics Products
న
www.thermofisher.com
www.microgenics.com
510-979-5000
510-979-5002 fax
Fremont, CA
94538-6406
46360 Fremont Blvd
4
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| Iron Binding Capacity, Total (TIBC) | Lipase |
|---|---|
| Lactic Acid | Lipoprotein (LPA) |
| LDH | Lithium |
| LDL-Cholesterol | Magnesium |
| Lidocaine | Methotrexate |
| Lipase | N-Acetylprocainamide, NAPA |
| Lipoprotein (a) | Osmolality |
| Lithium | Phenobarbital |
| Magnesium | Phenytoin |
| Methotrexate | Phosphorus |
| NAPA | Potassium |
| Osmolality | Prealbumin |
| Phenobarbital | Primidone |
| Phenytoin | Procainamide |
| Phosphorus | Pseudocholinesterase |
| Potassium | Quinidine |
| Prealbumin | Salicylate |
| Primidone | Sodium |
| Procainamide | Thyroxine Free T4* |
| Pseudocholinesterase (PCHE) | Thyroxine, Total T4 |
| Quinidine | Theophylline |
| Rheumatoid Factor (RF) | Thyroid Stimulating Hormone, TSH |
| Salicylate | Tobramycin |
| Sodium | Total Protein |
| Thyroxine, Total T4 | Transferrin* |
| Theophylline | Triglycerides |
| Thyroid Stimulating Hormone, TSH | Tricyclic Antidepressants |
| Tobramycin | Thiiodothyronine, Total T3* |
| Total Protein | Thiiodothyronine Free T3* |
| Transferrin | T-Uptake |
| Triglycerides | Unsaturated Iron Binding Capacity (UIBC)* |
| Tricyclic Antidepressants (TCA) | Uric Acid |
| T-Uptake | Valproic Acid |
| Unsaturated Iron Binding Capacity (UIBC) | Vancomycin |
| Uric Acid | |
| Valproic Acid | |
| Vancomycin | |
| Zinc |
Diagnostics Division
Microgenics Products
46360 Fremont Blvd
Fremont, CA
94538-6406
510-979-5000
510-979-5002 fax
www.themofisher.com
www.microgenics.com
9
5
hermoFisher . S
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Conclusion
As summarized, Omni-CORE is substantialy equivalent to the previously chem-TRAK H (K09205) and MAS
lmmunology (K960824) Controls. Substantial equivalence has been satsified.
Diagnostics Division
Microgenics Products
ﻟﺴﻨﺔ
ww.thermofisher.com
510-979-5000
510-979-5002 fax
Fremont, CA
94538-6406
16360 Fremont Blvc
6
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/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 circle is an abstract image of an eagle or bird-like figure.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
NOV 03 2011
Microgenics Corporation c/o Ms. Lisa Charter Manager, Regulatory Affairs 46360 Fremont Blvd. Fremont, CA 94538
Re: K110738 Trade Name: Thermo Scientific MAS® Omni-Core Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material Regulatory Class: Class I, Reserved Product Codes: JJY Dated: September 15, 2011 Received: September 20, 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 manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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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/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 number (800) 638-2041 or ( 301 ) 796-5680 or at its Internet address http://www.fda.goy/MedicalDevicesforYou/Industry/default.htm.
Sincerely yours,
signature
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
8
Indication for Use
510(k) Number (if known): K110738
Device Name: MAS® Omni•CORE
Indication for Use:
Thermo Scientific MAS® Omni•CORE™ is intended for use as an assayed control for monitoring assay conditions in many clinical laboratory determinations. Include MAS® Omni•CORE with patient serum specimens when assaying for any of the constituents. Assay values are provided for the specific systems listed. The user can compare observations with their expected ranges as a means of assuring consistent performance of reagent and instrument.
Prescription Use X (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
CARS
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K110738