ABBOTT ARCHITECT STAT TROPONIN I LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL L, M AND H

K041194 · Medical Analysis Systems, Inc. · JJX · Aug 16, 2004 · Clinical Chemistry

Device Facts

• Record ID: K041194
• Device Name: ABBOTT ARCHITECT STAT TROPONIN I LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL L, M AND H
• Applicant: Medical Analysis Systems, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Aug 16, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The intended use is for an Abbott instrument with the ARCHITECT STAT Troponin-I reagent and calibrator. The ARCHITECT® Troponin-I Controls are for verification of the accuracy and precision of the ARCHITECT i2000SR System when used for the quantitative determination of cardiac Troponin-I in human serum and plasma. Refer to the ARCHITECT STAT Troponin-I reagent package insert for additional information.

Device Story

Abbott ARCHITECT STAT Troponin-I Controls consist of recombinant human cardiac troponin-IC complex in BES buffer with protein stabilizers; used as quality control material for the ARCHITECT i2000SR System. Controls verify accuracy and precision of quantitative Troponin-I assays in human serum and plasma. Product supplied in three levels (L, M, H) in 3 mL vials. Clinical laboratory personnel use controls to monitor assay performance; results compared against established target ranges to ensure instrument and reagent consistency. Benefits include reliable verification of cardiac marker testing, supporting clinical decision-making for cardiac events.

Clinical Evidence

No clinical data. Bench testing only. Stability established via real-time and accelerated stress studies (Arrhenius). Target ranges and precision established using 140 replicates per control across two systems and two reagent lots; total CV% < 10%. Data evaluated using Grubs Test at 95% confidence.

Technological Characteristics

Recombinant human cardiac troponin-IC complex in BES buffer; protein stabilizers (human/fish); Proclin 5000 preservative. Three levels (L, M, H) in 3 mL vials. Stability: 12 months at -10 °C; 30 days at 2-8 °C. Designed for use with Abbott ARCHITECT i2000SR System.

Indications for Use

Indicated for use as a quality control material to verify the accuracy and precision of the ARCHITECT i2000SR system for the quantitative measurement of cardiac Troponin-I in human serum and plasma samples.

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:
k041194

B. Purpose of Submission:
Modified device - Removal of all analytes except for Troponin I from the reagent formulation of the previously cleared MAS® CardioImmune® TL, (k032335).

C. Analyte:
Troponin I

D. Type of Test:
Quality Control Material

E. Applicant:
Medical Analysis Systems, Inc.

F. Proprietary and Established Names:
Abbott ARCHITECT STAT Troponin I, Liquid Assayed Cardiac Marker Control, Level L, M and H

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:
JJX
4. Panel:
75

H. Intended Use:
1. Intended use(s):
The intended use is for an Abbott instrument with the ARCHITECT STAT Troponin-I reagent and calibrator. The ARCHITECT® Troponin-I Controls are for verification of the accuracy and precision of the ARCHITECT i2000SR System when used for the quantitative determination of cardiac Troponin-I in human serum and plasma. Refer to the ARCHITECT STAT Troponin-I reagent package insert for additional information.

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

The ARCHITECT® Troponin-I Controls are for verification of the accuracy and precision of the ARCHITECT i2000SR System when used for the quantitative determination of cardiac Troponin-I in human serum and plasma. Refer to the ARCHITECT STAT Troponin-I reagent package insert for additional information.

3. **Special condition for use statement(s):**

Prescription use

4. **Special instrument Requirements:**

Abbott ARCHITECT i2000SR System

**I. Device Description:**

The Abbott ARCHITECT STAT Troponin-I Controls contain a recombinant human cardiac troponin-IC complex in BES buffer with protein (human and fish) stabilizers. Human donor units have been tested and found to be non reactive for HBsAg, HIV-1 Ag, anti-HCV, and anti-HIV-1/HIV-2. Preservatives include antimicrobial and antifungal agents.

The controls are stable for 12 months from the date of manufacture when stored at -10 °C. Unopened and opened vials, when stored tightly capped, are stable for 30 days when stored at 2-8 °C.

This product will be sold in a kit with 2 vials of level L, M and H, in 3 mL vials.

**J. Substantial Equivalence Information:**

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

MAS® CardioImmune® TL Cardiac Marker Control

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

MAS® CardioImmune® TL k032335

3. **Comparison with predicate:**

| General Information | MAS® CardioImmune® TL | Abbott ARCHITECT STAT Troponin-I |
| --- | --- | --- |
| 501(k) Number | k032335 | K041194 |
| Product Code | JJY/JJX | JJX |
| Intended Use | For use in the clinical laboratory as an assayed control serum suitable for monitoring assay conditions in specific cardiac marker determinations. Include with patient serum specimens when assaying for any of the listed | The ARCHITECT® Troponin-I Controls are for verification of the accuracy and precision of the ARCHITECT i2000SR System when used for the quantitative determination of cardiac Troponin-I in human serum and plasma. |

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| | 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. | Refer to the ARCHITECT STAT Troponin-I reagent package insert for additional information. |
| --- | --- | --- |
| Product state at purchase | Frozen | Frozen |
| Stability Claims | 36 months unopened at -20 °C
180 days unopened at 2-8 °C
30 days opened at 2-8 °C | 12 months unopened at -10 °C
30 days unopened at 2-8 °C
30 days opened at 2-8 °C |
| Constituents | CK-MB, Creatinine Kinase-MB Isoenzyme | |
| | CRP | |
| | Digoxin | |
| | Myoglobin | |
| | Troponin-I | Troponin-I |
| | 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 |
| Preservatives | Sodium Azide | Proclin 5000 |

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

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):
Control target ranges were established using two Architect systems with the In-house Master Lot Calibrator and two lots of reagent. 140 replicates per control were run on each analyzer for four runs. Calibration replicates must fall within allowed range for the appropriate general specification. Total CV% for all replicates for each On-Test control for each system/reagent combination or run may not exceed

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10%. Grubs Test at a 95% Confidence is used to evaluate the data. A grand mean is calculated using all accepted values from the four runs (N=140). An interval of +/- 30% is calculated for the grand mean of each control. The published value of each control grand mean and range are reported to 2 decimal places.

Stability studies were performed using three lots on opened vials at 2-8 °C for 30 days on Levels L, M and H. The 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 4 °C

| | | Level L | | | Level M | | | Level H | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Analyte | Unit | Fresh | 30 days | % Change | Fresh | 30 days | % Change | Fresh | 30 days | % Change |
| Troponin-I | ng/mL | 0.136 | 0.139 | 1.9 | 0.557 | 0.554 | -0.5 | 14.896 | 14.567 | -2.3 |

Table 2. Real Time Data, Closed Vial Data, 30 days at 4 °C

| | | Level L | | | Level M | | | Level H | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Analyte | Unit | Fresh | 30 days | % Change | Fresh | 30 days | % Change | Fresh | 30 days | % Change |
| Troponin-I | ng/mL | 0.146 | 0.138 | -5.8 | 0.556 | 0.560 | 0.7 | 14.608 | 14.710 | 0.8 |

Arrhenius studies were performed to establish shelf life (12 months) 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 30 days at 4 °C. Results are tabulated in Table 3 for Level L, M and Level H.

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

| | | Level L | | | Level M | | | Level H | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Analyte | Unit | Fresh | 30 days | % Change | Fresh | 30 days | % Change | Fresh | 30 days | % Change |
| Troponin-I | ng/mL | 0.146 | 0.138 | -5.8 | 0.556 | 0.560 | 0.7 | 14.608 | 14.710 | 0.8 |

The following concentration ranges may be used for individual replicate control specifications on the ARCHITECT i2000SR:

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| Control | Target Concentration | | Range | |
| --- | --- | --- | --- | --- |
| | Ng/mL μg/L | | ng/mL | μg/L |
| Control L | 0.13 | 0.13 | 0.09 – 0.17 | 0.09 – 0.17 |
| Control M | 0.56 | 0.56 | 0.39 – 0.73 | 0.39 – 0.73 |
| Control H | 15.77 | 15.77 | 11.04 – 20.50 | 11.04 –20.50 |

The manufacturer recommends that each laboratory should establish its own concentration ranges for new control lots at each control level.

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

4. Clinical cut-off: NA

5. Expected values/Reference range: See the target ranges provided above in traceability.

N. Conclusion:

The submitted material in this premarket is complete and supports a substantially equivalence decision.