MAS CARDIOIMMUNE PROBNP, MAS CARDIOIMMUNE TL

K032335 · Medical Analysis Systems, Inc. · JJY · Aug 19, 2003 · Clinical Chemistry

Device Facts

• Record ID: K032335
• Device Name: MAS CARDIOIMMUNE PROBNP, MAS CARDIOIMMUNE TL
• Applicant: Medical Analysis Systems, Inc.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Aug 19, 2003
• 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 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. The MAS® CardioImmune® proBNP 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® proBNP 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 and MAS® CardioImmune® proBNP are assayed control sera used in clinical laboratories. These products serve as quality control materials to monitor the performance of cardiac marker assays. Laboratory technicians include these controls alongside patient serum specimens during routine testing. By comparing observed assay values against provided expected ranges, users verify the consistency and accuracy of their reagent and instrument systems. This process ensures reliable clinical results for cardiac marker determinations, aiding healthcare providers in maintaining diagnostic quality.

Clinical Evidence

No clinical data; bench testing only. The device is an assayed control material; performance is verified through analytical assay value assignment and comparison against expected ranges for specific clinical laboratory systems.

Technological Characteristics

Liquid stable control material; human serum base; additives include pure chemicals, recombinant proteins, human tissue/body fluid derivatives, preservatives, and stabilizers. No energy source or software. Storage requirements: -20°C (unopened) or 2-8°C (unopened/opened).

Indications for Use

Indicated for use in clinical laboratories as an assayed control serum to monitor assay performance for cardiac marker determinations. Used by laboratory personnel to verify consistency of reagents and instruments during patient specimen testing.

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: K032335
B. Analyte: N/A
C. Type of Test: N/A
D. Applicant: Medical Analysis Systems, Inc.
E. Proprietary and Established Names: MAS® CardioImmune® proBNP
MAS® CardioImmune® TL
Liquid Assayed Cardiac Marker Control

F. 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
4. Panel: 75

G. Intended Use:
1. Intended use(s):

MAS® CardioImmune® proBNP 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® proBNP 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.

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.

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2. **Indication(s) for use:**

The MAS® CardioImmune® proBNP 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® proBNP 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.

The 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 constituent performance of reagent and instrument.

3. **Special condition for use statement(s):** None

4. **Special instrument Requirements:** None

**H. Device Description:**

The MAS® CardioImmune proBNP and MAS® CardioImmune TL products are 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.

**I. Substantial Equivalence Information:**

1. **Predicate device name(s):**

MAS® CardioImmune® TL

MAS® CardioImmune® proBNP

2. **Predicate K number(s):**

MAS® CardioImmune® TL K013995

MAS® CardioImmune® proBNP K031364

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3. Comparison with predicate:

| General Information | MAS® CardioImmne® TL | MAS® CardioImmune® proBNP | MAS® CardioImmune® TL MAS® CardioImmune® proBNP |
| --- | --- | --- | --- |
| 501(k) Number | K013995 | K031364 | K032335 |
| Product Code | JJY | JJY | JJY |
| Intended Use | For use in the clinical laboratory as an assayed control serum suitable for monitoring assay conditions in specific cardiac marker determinations. Include 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. | For use in the clinical laboratory as an assayed control serum suitable for monitoring assay conditions in specific cardiac marker determinations. Include 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. | For use in the clinical laboratory as an assayed control serum suitable for monitoring assay conditions in specific cardiac marker determinations. Include 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 | Liquid | Liquid | Liquid |
| Stability Claims | 36 months unopened at -20°C 180 days unopened at 2-8°C, 30 days opened at 2-8°C | 24 months unopened at -20°C 30 days unopened at 2-8°C, 30 days opened at 2-8°C | 36 months unopened at -20°C 90 days unopened at 2-8°C, 60 days unopened for Troponin T, 30 days opened at 2-8°C |
| Constituents | CK-MB, Creatinine | CK-MB, Creatinine | CK-MB, Creatinine |

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| | Kinase-MB Isoenzyme | Kinase-MB Isoenzyme BNP | Kinase-MB Isoenzyme BNP |
| --- | --- | --- | --- |
| | CRP | CRP | CRP |
| | Digoxin | Digoxin | Digoxin |
| | Myoglobin | Myoglobin | Myoglobin |
| | Troponin I | Troponin I | Troponin I |
| | | | Troponin - T |
| Configuration | Each level sold separately Multi Pack - several vials of each level Sample Pack – one vial of each level | Each level sold separately Multi Pack - several vials of each level Sample Pack – one vial of each level | Each level sold separately Multi Pack - several vials of each level Sample Pack – one vial of each level |

J. Standard/Guidance Document Referenced (if applicable):
FDA guidance “Points to Consider Guidance Document on Assayed and Unassayed Quality Control Materials”.

K. Test Principle: NA

L. Performance Characteristics (if/when applicable):

1. Analytical performance:
a. Precision/Reproducibility: NA
b. Linearity/assay reportable range: NA
c. Traceability (controls, calibrators, or method): Not Stated
d. Detection limit: NA
e. Analytical specificity: NA
f. Assay cut-off: NA

2. Comparison studies:
a. Method comparison with predicate device: NA
b. 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

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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.

M. Conclusion:

Based on the information provided, I recommend that the MAS® CardioImmune® proBNP and MAS CardioImmune® TL Liquid Assayed Cardiac Marker Control is substantially equivalent to the predicate device.