ELECSYS PRECICONTROL TROPONIN T

K031990 · Roche Diagnostics Corp. · JJX · Aug 20, 2003 · Clinical Chemistry

Device Facts

• Record ID: K031990
• Device Name: ELECSYS PRECICONTROL TROPONIN T
• Applicant: Roche Diagnostics Corp.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Aug 20, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The Elecsys® PreciControl Troponin T is used for quality control of the Elecsys Troponin T (Cardiac T®) immunoassay on the Elecsys immunoassay system.

Device Story

Elecsys PreciControl Troponin T is a lyophilized quality control product; consists of two levels (Low and High) of recombinant human Troponin T in human serum matrix. Used on Elecsys immunoassay systems to monitor assay performance. Requires reconstitution with 2 mL distilled water; 15-minute standing time. Provides target concentration values for Troponin T to verify system accuracy and precision. Used by laboratory personnel in clinical settings.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Lyophilized quality control material; recombinant human Troponin T in human serum matrix. Two levels (Low/High). Reconstituted with 2 mL distilled water. Storage 2–8°C. Compatible with Elecsys immunoassay systems.

Indications for Use

Indicated for quality control of the Elecsys Troponin T (Cardiac T) immunoassay on Elecsys immunoassay systems.

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

• Elecsys® PreciControl Cardiac (K983492)

Submission Summary (Full Text)

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

A. 510(k) Number: K031990
B. Analyte: Troponin T
C. Type of Test: NA
D. Applicant: Roche Diagnostics Corporation.
E. Proprietary and Established Names: Roche Elecsys® PreciControl Troponin T

F. Regulatory Information:
1. Regulation section: 21 CFR §862.1660 Quality control material (assayed and unassayed).
2. Classification: Class I
3. Product Code: JJX
4. Panel: 75

G. Intended Use:
1. Intended use(s):
PreciControl Troponin T is used for quality control of the Elecsys Troponin T (Cardiac T) immunoassay on the Elecsys immunoassay systems.
2. Special condition for use statement(s): None
3. Special instrument Requirements: None

H. Device Description:
The Elecsys® PreciControl Troponin T is a lyophilized product consisting of two (2) levels, a Low Level, and High Level control manufactured using recombinant human Troponin T in human serum matrix. The analyte is spiked into the PreciControl Matrix to the correct concentration levels.

I. Substantial Equivalence Information:
1. Predicate device name(s):
Elecsys® PreciControl Cardiac

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2. Predicate K number(s): K983492

3. Comparison with predicate:

Similarities between Predicate Device and Proposed Elecsys® PreciControl Troponin T

| Characteristics | Predicate Device (K983492) | Proposed Product |
| --- | --- | --- |
| Device Brand Name | Elecsys® PreciControl Cardiac | Elecsys® PreciControl Troponin T |
| Immunoassay System | Elecsys immunoassay systems | Elecsys immunoassay systems |
| Format | Lyophilized, based on human serum | Lyophilized, based on human serum |
| Handling | Reconstitute with 2 ml of distilled water and allow to stand closed for 15 minutes | Reconstitute with 2 ml of distilled water and allow to stand closed for 15 minutes |
| Storage Conditions | 2 – 8° C | 2 – 8° C |
| Intended Use | Used for quality control of the Elecsys CK-MB, Troponin T (Cardiac T®), and Myoglobin immunoassays using the Elecsys immunoassay system. | Used for quality control of the Elecsys Troponin T (Cardiac T®) immunoassay using the Elecsys immunoassay system. |

Differences between Predicate Device and Proposed Elecsys® PreciControl Troponin T

| Characteristics | Predicate Device (K983492) | Proposed Product |
| --- | --- | --- |
| Analytes | Troponin T (human recombinant) CK-MB (human) Myoglobin (human) | Troponin T (human recombinant) |
| Concentrations of Troponin T | Low: Approx 0.15 ng/mL
High: Approx 5 ng/mL | Low: Approx 0.15 ng/mL
High: Approx 2.5 ng/mL |
| Stability | Unopened: Stable at 2-8°C until expiration date on vial
Open Vial: (reconstituted): 20 - 25°C : 3 hours at 2 - 8°C : 3 days - 20°C: 3 months (freeze only once) | Unopened: Stable at 2-8°C until expiration date on vial
Open Vial: (reconstituted): 20 - 25°C : 3 hours at 2 - 8°C : 3 days - 20°C: 3 months (freeze only once) |

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

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b. Linearity/assay reportable range: NA
c. Traceability (controls, calibrators, or method):

The Elecsys PreciControl Troponin T is a lyophilized manufactured control using recombinant human Troponin T in a human serum matrix. The analyte is spiked into the matrix to the correct concentration levels.

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:

## Proposed Mean and Target Ranges

Approximate target values are given in the table below. Lot-specific target values may differ slightly after value assignment.

| PreciControl Troponin T | Approximate Target Values |
| --- | --- |
| Low | 0.1 ng/mL |
| High | 2.5 ng/mL |

## M. Conclusion:

Based on the information provided, I recommend that the Roche Elecsys® PreciControl Troponin T is substantially equivalent to the currently marketed Elecsys® PreciControl Cardiac (K983492).