THERMO SCIENTIFIC MAS OMNI-CORE

K110738 · Microgenics Corporation · JJY · Nov 3, 2011 · Clinical Chemistry

Device Facts

• Record ID: K110738
• Device Name: THERMO SCIENTIFIC MAS OMNI-CORE
• Applicant: Microgenics Corporation
• Product Code: JJY · Clinical Chemistry
• Decision Date: Nov 3, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

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.

Device Story

MAS® Omni•CORE is a liquid stable, human serum-based control material used in clinical laboratories to monitor assay performance. It contains various analytes, including drugs, metabolites, and purified chemicals, with specific enzymes derived from porcine, bovine, and avian tissues. The control is provided in three levels to cover different concentration ranges. Laboratory technicians include the control alongside patient serum specimens during routine testing. By comparing the observed assay values against provided expected ranges, clinicians verify the consistency and accuracy of their reagent and instrument systems. This process helps ensure reliable clinical results for patient diagnosis and monitoring.

Clinical Evidence

No clinical data. Bench testing only. Stability evaluated via recovery differences between fresh and stored samples (open/closed vial). Value assignment established using data from 2-3 laboratories over 2-3 days.

Technological Characteristics

Liquid stable control material; human serum base; additives include porcine, bovine, and avian tissue extracts. Three levels (1, 2, 3). Storage: -20°C. Shelf life: 3 years. Analyte ranges established at ±20% or ±3SDs. No software, electronics, or energy source.

Indications for Use

Indicated for use as an assayed quality control material in clinical laboratories to monitor the performance of reagents and instruments during the analysis of patient serum specimens. No specific patient population, age, or gender restrictions apply as the device is a laboratory control.

Regulatory Classification

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.

Predicate Devices

• MAS®Chem-TRAK H (k092051)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE

A. 510(k) Number:
k110738

B. Purpose for Submission:
New device

C. Measurand:
Quality control materials for multiple immunoassay analytes

D. Type of Test:
Not applicable

E. Applicant:
Microgenics Corporation

F. Proprietary and Established Names:
MAS Omni-Core

G. Regulatory Information:
| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| JJY | Class I, reserved | 862.1660 | Clinical Chemistry (75) |

H. Intended Use:

1. Intended use(s):
Refer to indications for use below

2. Indication(s) for use:
Thermo Scientific MAS Omni-Core is intended for use an assayed control for monitoring assay conditions in many clinical laboratory determinations. Include

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Omni-Core 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 their expected ranges as a means of assuring consistent performance of reagent and instrument.

3. Special conditions for use statement(s):

For in vitro diagnostic use

For prescription use

4. Special instrument requirements:

For use with the specific systems listed in the package insert

I. Device Description:

The Omni-Core controls are 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, alanine aminotransferase, creatine kinase and lipase are obtained from porcine tissue; alkaline phosphatase and gamma glutamyl transferase are from bovine tissue; lactate dehydrogenase is from avian tissue. Preservatives and stabilizers are added to maintain product integrity. Controls are provided in frozen liquid form

Omni-CORE is prepared from components which are derived from human source material have been tested and found non-reactive for Hepatitis B Surface Antigen (HBsAg), Hepatitis C (HCV), HIV-1 and HIV-2.

The control is offered in three levels (1, 2, or 3) or in combination.

J. Substantial Equivalence Information:

1. Predicate device name(s):

MAS®Chem-TRAK H

2. Predicate 510(k) number(s):

k092051

3. Comparison with predicate

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| | Candidate Device
k110738 | Predicate
Mas Chem TRAK H
k092051 |
| --- | --- | --- |
| Indications for Use | Intended for monitoring assay conditions in many clinical laboratory determinations. | Same |
| Analyte | Multiple analytes | Same |
| Matrix | Human serum | Same |
| Format | Frozen Liquid | Frozen liquid |
| Number of levels | 3 | Same |
| Shelf life | 3 years -20 degrees C | 2.5 years at -20 degrees C |
| Assigned analytes: | Acetaminophen | Acetaminophen |
| --- | --- | --- |
| | Albumin | Albumin |
| | ALK Phos. (Alkaline Phosphatase) | Alkaline Phosphatase, |
| | alpha-1-Acid Glycoprotein | |
| | Alpha-1-Antitrypsin | |
| | Alpha-2-Macroglobulin | |
| | Alanine Aminotransferase | Alanine Aminotransferase |
| | Amikacin | Amikacin |
| | Amylase | Amylase – |
| | Antistreptolysin 0 (ASO) - | |
| | Apolipoprotein A1 | Apolipoprotein A (APO A) |
| | Apolipoprotein B | Apolipoprotein B (APO B) |
| | Aspartate Aminotransferase | Aspartate Aminotransferase, |
| | Beta 2 Microglobulin | |
| | Bile Acids | |
| | Direct Bilirubin, | Direct Bilirubin, |
| | Total Bilirubin | Total Bilirubin |
| | Blood Urea Nitrogen, | Blood Urea Nitrogen |
| | C3 Complement | C3 Complement |
| | C4 Complement | C4 Complement |

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| | Caffeine | Caffeine |
| --- | --- | --- |
| | Calcium | Calcium |
| | Carbamazepine | Carbamazepine – |
| | Ceruloplasmin | |
| | Chloride | Chloride |
| | Cholesterol | Cholesterol |
| | Creatine Kinase | Creatine Kinase |
| | CO2 | CO2 |
| | Copper | |
| | Cortisol | |
| | C-Reactive Protein (CRP) | C-Reactive Protein, CRP |
| | Creatinine | Creatinine |
| | Digoxin | Digoxin |
| | Disopyramide | Disopyramide |
| | Ethanol | Ethanol |
| | Ethosuximide | Ethosuximide |
| | Ferritin | Ferritin |
| | Gentamicin | Gentamicin |
| | Gamma Glutamyltransferase | Gamma Glutamyltransferase |
| | Glucose | Glucose |
| | Haptoglobin | Haptoglobin |
| | HDL Cholesterol | HDL Cholesterol |
| | - | Human Chorionic Gonadotrophin |
| | IgA | IgA |
| | IgE | - |
| | IgG | IgG |
| | IgM | IgM |
| | - | |
| | - | |
| | Iron | Iron |
| | Lactic Acid | Lactic Acid |
| | LDH | LDH |
| | LDL-Cholesterol | LDL-Cholesterol |
| | Lidocaine | Lidocaine |
| | Lipase | Lipase |
| | Lipoprotein (a) | Lipoprotein (LpA) |
| | Lithium | Lithium |
| | Magnesium | Magnesium |
| | Methotrexate | Methotrexate |
| | N-Acetylprocainamide, | N-Acetylprocainamide |
| | Osmolality | Osmolality |

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| | Phenobarbital | Phenobarbital |
| --- | --- | --- |
| | Phenytoin | Phenytoin |
| | Phosphorus | Phosphorus |
| | Potassium | Potassium |
| | Prealbumin | |
| | Primidone | |
| | Procainamide | |
| | Pseudocholinesterase | Pseudocholinesterase |
| | Quinidine | Quinidine |
| | | |
| | RF | |
| | Salicylate | Salicylate |
| | Sodium | Sodium |
| | T3 uptake | T3 uptake |
| | Thyroxine Total T4 | Thyroxine Total T4 |
| | Theophylline | Theophylline |
| | Thyroid Stimulating Hormone, TSH | Thyroid Stimulating Hormone, TSH |
| | Tobramycin | Tobramycin |
| | Total Iron Binding Capacity | Total Iron Binding Capacity |
| | Total Protein | Total Protein |
| | Transferrin | Transferrin |
| | Triglycerides | Triglycerides |
| | Tricyclic Antidepressants | Tricyclic Antidepressants |
| | Uric Acid | Uric Acid |
| | Valproic Acid | Valproic Acid |
| | Vancomycin | Vancomycin |
| | Zinc | |

K. Standard/Guidance Document Referenced (if applicable):

None were referenced

L. Test Principle:

Not applicable

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

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a. Precision/Reproducibility:

Not applicable

b. Linearity/assay reportable range:

Not applicable

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

Analyte components:

| Target values: | Level 1 | Level 2 | Level 3 | units |
| --- | --- | --- | --- | --- |
| Acetaminophen | 25 | 82.5 | 140 | ug/mL |
| Albumin | 2.5 | 5 | 7.5 | g/dL |
| Alkaline Phosphatase | 45 | 197.5 | 350 | U/L |
| alpha-1-Acid Glycoprotein | 43 | 85 | 127 | mg/dL |
| alpha-1-Antitrypsin | 77 | 153.5 | 230 | mg/dL |
| alpha-2-Macroglobulin | 90 | 178 | 280 | mg/dL |
| ALT | 40 | 120 | 200 | U/L |
| Amikacin | 5 | 17.5 | 30 | ug/mL |
| Amylase | 90 | 320 | 550 | U/L |
| Antistreptolysin O | 89 | 194.5 | 300 | IU/mL |
| Apolipoprotein A1 | 90 | 160 | 230 | mg/dL |
| Apolipoprotein B | 46 | 103 | 160 | mg/dL |
| AST | 40 | 155 | 270 | U/L |
| Beta 2 Microglobulin | 1.5 | 6.5 | 10 | mg/L |
| Bile Acids | 4.5 | 8 | 10 | umol/L |
| Direct (DBIL) Bilirubin, | 0.6 | 2.38 | 3.75 | mg/dL |
| Total (BILT) | 1 | 4.1 | 7.2 | mg/dL |
| BUN | 15 | 40 | 65 | mg/dL |
| C3 Complement | 79 | 170.5 | 262 | mg/dL |
| C4 Complement | 20 | 35 | 50 | mg/dL |
| Caffeine | 5 | 12 | 20 | ug/mL |
| Calcium | 6.5 | 9.25 | 12 | mg/dL |
| Carbamazepine | 4 | 9 | 14 | ug/mL |
| Ceruloplasmin | 17 | 38.5 | 60 | mg/dL |
| Chloride | 85 | 95 | 105 | mMol/L |
| Cholesterol | 115 | 167.5 | 220 | mg/dL |
| CK | 90 | 345 | 600 | U/L |
| CO2 | 16 | 24 | 32 | mMol/L |
| Cortisol | 4 | 19.5 | 35 | ug/dL |

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| C-Reactive Protein | 0.8 | 3.9 | 7 | mg/dL |
| --- | --- | --- | --- | --- |
| Creatinine | 1 | 4 | 7 | mg/dL |
| Digoxin | 1 | 1.85 | 2.7 | ng/mL |
| Disopyramide | 1.5 | 3 | 5 | ug/mL |
| Ethanol | 20 | 100 | 180 | mg/dL |
| Ethosuximide | 35 | 100 | 150 | ug/mL |
| Ferritin | 25 | 195 | 370 | ng/mL |
| Gentamicin | 1.7 | 4.35 | 7 | ug/mL |
| GGT | 40 | 95 | 150 | mg/dL |
| Glucose | 65 | 207.5 | 350 | mg/dL |
| Haptoglobin | 64 | 139 | 214 | mg/dL |
| HDL Cholesterol | 30 | 50 | 70 | mg/dL |
| IgA | 134 | 268 | 402 | mg/dL |
| IgE | 152 | 286 | 420 | IU/mL |
| IgG | 541 | 1270 | 2000 | mg/dL |
| IgM | 58 | 109.5 | 161 | mg/dL |
| Iron | 75 | 152.5 | 240 | ug/dL |
| Lactic Acid | 1.25 | 3.875 | 6.5 | mMol/L |
| LDH | 100 | 225 | 350 | U/L |
| LDL-Cholesterol | 45 | 72.5 | 100 | mg/dL |
| Lidocaine | 1.5 | 4.75 | 8 | ug/mL |
| Lipase | 225 | 312.5 | 400 | U/L |
| Lipoprotein (a) | 4 | 9.5 | 15 | mg/dL |
| Lithium | 0.8 | 1.5 | 2.2 | mEq/dL |
| Magnesium | 1 | 2.75 | 4.5 | mg/dL |
| Methotrexate | 0.35 | 2.5 | 2.8 | uMol/L |
| NAPA | 3 | 8 | 13 | ug/mL |
| Phenobarbital | 10 | 30 | 50 | ug/mL |
| Phenytoin | 5 | 13.5 | 22 | ug/mL |
| Phosphorus | 2.2 | 4.85 | 7.5 | mg/dL |
| Potassium | 2.5 | 4.25 | 6 | mEq/L |
| Prealbumin | 12 | 28.5 | 45 | mg/dL |
| Primidone | 4 | 11 | 18 | ug/mL |
| Procainamide | 3 | 7.5 | 12 | ug/mL |
| Pseudocholinesterase | 2.5 | 6.5 | 10.5 | U/mL |
| Quinidine | 1.5 | 3.75 | 6 | ug/mL |
| RF | 45 | 72.5 | 100 | IU/mL |
| Salicylate | 7 | 11 | 15 | mg/dL |
| Sodium | 115 | 130 | 145 | mEq/dL |
| Thyroxine, Total T4 | 7 | 12 | 17 | ug/dL |
| Theophylline | 5 | 15 | 25 | ug/mL |
| Tobramycin | 1.5 | 4.5 | 7.5 | ug/mL |
| Total Protein | 4.5 | 8.25 | 12 | g/dL |
| Transferrin | 150 | 285 | 420 | mg/dL |
| Triglycerides | 90 | 155 | 220 | mg/dL |

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| Thyroid Stimulating Hormone, TSH | 2.5 | 9 | 14 | uIU/mL |
| --- | --- | --- | --- | --- |
| Tricyclic Antidepressants (TCA) | 40 | 100 | 180 | ng/mL |
| Uric Acid | 3.3 | 7.15 | 11 | mg/dL |
| Valproic Acid | 25 | 72.5 | 120 | ug/mL |
| Vancomycin | 7.5 | 21.25 | 35 | ug/mL |

In addition, the following analytes are not set to a specific range, but are assigned as found in human serum. These include: copper, total iron binding capacity, osmolality, T3-uptake, and zinc.

## Value Assignment:

Value assignment ranges for controls are established at $\pm 20\%$ or $\pm 3\mathrm{SDs}$ around the mean, whichever is broader. Narrower ranges (such as $\pm 2\mathrm{SDs}$ or $\pm 15\%$) may be used as long as the min and max values in the data set are within the established ranges. Data are collected from two or three different laboratories over two or three separate days.

## Stability:

Stability under the following conditions are evaluated.

| Stability condition | Stability evaluated by: | Stability claim: |
| --- | --- | --- |
| Open Vial Stability between 2-8°C | Recovery difference fresh vs. 30 day open vial. | 14 days for bilirubin (30 days for all other analytes) |
| Closed Vial Stability between 2-8°C | Recovery difference fresh vs. 30 day closed vial. | 30 days |
| Closed vial stability at–20°C | Recovery at zero time versus recovery at test date. | Currently labeled for 3 years. |

The package insert states that laboratories should establish internal mean and range criteria based upon local test system evaluation and tolerance limits.

d. Detection limit:

Not applicable

e. Analytical specificity:

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Not applicable

f. Assay cut-off:
Not applicable

2. Comparison studies:
a. Method comparison with predicate device:
Not applicable
b. Matrix comparison:
Not applicable

3. Clinical studies:
a. Clinical Sensitivity:
Not applicable
b. Clinical specificity:
Not applicable
c. Other clinical supportive data (when a. and b. are not applicable):
Not applicable

4. Clinical cut-off:
Not applicable

5. Expected values/Reference range:
The expected values are provided in the labeling for each specific lot.

N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

O. Conclusion:
The submitted information in this premarket notification is complete and supports substantial equivalence decision.