MAS CARDIOIMMUNE TL LIQUID ASSAYED CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3

K040880 · Medical Analysis Systems, Inc. · JJY · Apr 28, 2004 · Clinical Chemistry

Device Facts

• Record ID: K040880
• Device Name: MAS CARDIOIMMUNE TL LIQUID ASSAYED CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3
• Applicant: Medical Analysis Systems, Inc.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Apr 28, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The MAS® CardioImmune® TL is intended for use in the clinical laboratory as an assayed control scrum suitable for monitoring assay conditions in specific cardiac marker determinations. Include this product 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.

Device Story

MAS® CardioImmune® TL is a liquid stable control material derived from human serum; supplemented with recombinant proteins, human tissue/fluid preparations, and pure chemicals to achieve specific analyte levels. Used in clinical laboratories by technicians to monitor assay performance for cardiac markers. The control is processed alongside patient samples; the healthcare provider compares observed values against expected ranges provided in the lot-specific package insert. This monitoring ensures consistency of reagents and instruments, aiding in the validation of clinical test results for cardiac marker determinations.

Clinical Evidence

No clinical data; bench testing only. The device is an assayed control material; performance is validated through comparison of assay values against established expected ranges for specific cardiac marker systems.

Technological Characteristics

Liquid stable control material; human serum base; contains recombinant proteins and pure chemicals; stabilizers and preservatives added. Three levels available. Storage: -20 °C (unopened, 36 months) or 2-8 °C (opened, 30 days).

Indications for Use

Indicated for use in clinical laboratories as an assayed control serum to monitor assay performance for specific cardiac markers in patient serum specimens.

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.

Submission Summary (Full Text)

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

A. 510(k) Number: K040880
B. Purpose of Submission: Removal of Digoxin and the addition of Digitoxin to the reagent formulation of the previously cleared MAS® CardioImmune® TL, (K032335)
C. Analyte: N/A
D. Type of Test: N/A
E. Applicant: Medical Analysis Systems, Inc.
F. Proprietary and Established Names: MAS® CardioImmune® TL Liquid Assayed Cardiac Marker Control Level 1, 2 and 3

## G. Regulatory Information:

1. Regulation section: 21 CFR §862.1660 Quality control material (assayed and unassayed).
2. Classification: Class I, non-exempt
3. Product Code: JJY / JJX
4. Panel: 75

## H. Intended Use:

1. Intended use(s):

MAS® CardioImmune® TL is intended for use in the clinical laboratory as an assayed control serum suitable for monitoring assay conditions in specific cardiac marker determinations. Include CardioImmune® TL 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.

2. Indication(s) for use:

The MAS® CardioImmune® TL is intended for use in the clinical laboratory as an assayed control serum suitable for monitoring assay conditions in specific

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cardiac marker determinations. Include this product 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 constituent performance of reagent and instrument.

3. Special condition for use statement(s): None
4. Special instrument Requirements: The intended instruments are stated in the package insert.

I. Device Description:

The MAS® CardioImmune TL is a liquid stable control material prepared from human serum. Analyte levels are adjusted with various pure chemicals and preparations from recombinant proteins, human tissue or body fluids. Preservatives and stabilizers are added to maintain product integrity.

This product will be sold in a kit with 2 vials of level 1, 2 and 3, in 3 mL vials, or as a single level kit of 6 vials. These controls may be distributed with various combinations of the cleared analytes and the lot specific analytes claimed will be reflected by the lot specific package insert. The product may be sold as a single analyte cardiac marker.

J. Substantial Equivalence Information:

1. Predicate device name(s):

MAS® CardioImmune® TL Cardiac Marker Control

2. Predicate K number(s):

MAS® CardioImmune® TL K032335

2. Comparison with predicate:

| General Information | MAS® CardioImmune® TL
MAS® CardioImmune® proBNP | MAS® CardioImmune® TL |
| --- | --- | --- |
| 501(k) Number | K032335 | K040880 |
| Product Code | JJY | JJY / JJX |
| Intended Use | For use in the clinical laboratory as an assayed control serum suitable for monitoring assay conditions in specific cardiac | For use in the clinical laboratory as an assayed control serum suitable for monitoring assay conditions in specific cardiac |

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| General Information | MAS® CardioImmne® TL
MAS® CardioImmune® proBNP | MAS® CardioImmune® TL |
| --- | --- | --- |
| | marker determinations. Include 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. | marker determinations. Include 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 state at purchase | Frozen | Frozen |
| Stability Claims | 36 months unopened at -20 °C
30 days opened at 2-8 °C
180 days unopened at 2-8 °C except for,
proBNP, 90 days unopened at 2-8 °C
Troponin T, 60 days unopened at 2-8 °C | 36 months unopened at -20 °C
30 days opened at 2-8 °C
180 days unopened at 2-8 °C except for,
Digitoxin, 30 days, unopened at 2-8 °C
proBNP, 90 days unopened at 2-8 °C
Troponin T, 60 days opened at 2-8 °C |
| Constituents | Brain Natriuretic Peptide, BNP | Brain Natriuretic Peptide, BNP |
| | CK-MB, Creatinine Kinase-MB Isoenzyme | CK-MB, Creatinine Kinase-MB Isoenzyme |
| | CRP | CRP |
| | | *Digitoxin |
| | Digoxin | |
| | Myoglobin | Myoglobin |
| | Troponin-I | Troponin I |
| | Troponin-T | Troponin-T |
| Levels available | Three | Three |
| Configuration | 6 x 3 mL vials each level
2 x 3 x 3 mL, 2 vials of each level | 6 x 3 mL vials each level
2 x 3 x 3 mL, 2 vials of each level |

*Addition in bold.

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

FDA guidance “Points to Consider Guidance Document on Assayed and Unassayed Quality Control Material”.

## L. Test Principle: NA

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# M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility: NA
b. Linearity/assay reportable range: NA
c. Traceability (controls, calibrators, or method): Material (digitoxin) was purchased by the sponsor based on the manufacturer's certificate of analysis.

Stability studies performed using three lots on opened and unopened vials at 2-8 °C for 30 days resulted in no significant decline in performance. Studies were performed on Levels 1 and 3 only since Level 2 is a combination of the other two levels, for both opened and unopened vials. Results are listed below in Table 1 (Open Vial) and Table 2 (Closed Vial).

Table 1. Real Time Stability Data, Open Vial, 30 days at 2-8 °C

| | | Level 1 | | | Level 3 | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Analyte | Unit | Fresh | 30 days | % Change | Fresh | 30 days | % Change |
| Digitoxin | ng/mL | 11.23 | 11.30 | 0.02 | 39.53 | 40.80 | 0.03 |

Table 2. Real Time Data, Closed Vial Data, 30 days at 2-8 °C

| | | Level 1 | | | Level 3 | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Analyte | Unit | Fresh | 30 days | % of Day 0 | Fresh | 30 days | % of Day 0 |
| Digitoxin | ng/mL | 10.10 | 10.10 | 0.00 | 38.65 | 40.20 | 0.04 |

Arrhenius studies were performed to establish shelf life dating for this product. The analyte levels of three lots were based on the targeted high and low ranges for the product. The lots were stressed for 7 days at 37 °C. Results are tabulated in Table 3 for Level 1 and Level 3.

Table 3. Accelerated Stress Stability Data, 7 days at 37 °C

| | | Level 1 | | | Level 3 | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Analyte | Unit | Fresh | 7 days | % Change | Fresh | 7 days | % Change |
| Digitoxin | ng/mL | 11.57 | 11.63 | 0.01 | 38.87 | 37.13 | -0.04 |

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The Arrhenius data demonstrate that the shelf life for this product is greater than 3 years when stored at or below $-20^{\circ}\mathrm{C}$ .

d. Detection limit: NA
e. Analytical specificity: NA
f. Assay cut-off: NA

# 2. Comparison studies:

g. Method comparison with predicate device: NA
h. Matrix comparison: NA

# 3. Clinical studies:

a. Clinical sensitivity: NA
b. Clinical specificity: NA
c. Other clinical supportive data (when $a$ and $b$ are not applicable): NA

# 4. Clinical cut-off: NA

# 5. Expected values/Reference range:

The assigned ranges for these controls are based upon replicate assays of representative samples of the product by participating laboratories in accordance with established protocol. All values have been assigned with instruments and instrument manufacturer's reagents available at the time of assay. Subsequent instrument or reagent modifications may invalidate these assigned ranges.

Expected values may vary slightly with different reagent and/or methodologies used. Refer to the included table for values obtained for specific systems. Values listed are specific for this lot of control only. Good laboratory practice suggests that each laboratory establish its own parameters. The proposed range and mean for digitoxin is listed below in Table 4.

Table 4. Proposed Mean and Ranges

| Analyte | Unit | Level 1 Mean (Range) | Level 2 Mean (Range) | Level 3 Mean (Range) |
| --- | --- | --- | --- | --- |
| Digitoxin | ng/mL | 11 (9-13) | 21.5 (19-24) | 47 (35-50) |

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N. Conclusion:
The submitted material in this premarket notification for MAS CardioImmune® TL Liquid Assayed Cardiac Marker Control is complete and supports a substantially equivalence decision.