I-STAT CARDIAC MARKERS CONTROL LEVEL 1, 2, AND 3; CARDIAC MARKERS CALIBRATION VERIFICATION CONTROL SET

K031873 · I-Stat Corporation · JJX · Oct 7, 2003 · Clinical Chemistry

Device Facts

• Record ID: K031873
• Device Name: I-STAT CARDIAC MARKERS CONTROL LEVEL 1, 2, AND 3; CARDIAC MARKERS CALIBRATION VERIFICATION CONTROL SET
• Applicant: I-Stat Corporation
• Product Code: JJX · Clinical Chemistry
• Decision Date: Oct 7, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The i-STAT Cardiac Markers Controls are used to verify the integrity of newly received i-STAT cTnI cartridges. The i-STAT Cardiac Markers Calibration Verification Control Set is used to verify the accuracy of results over the measurement range of the i-STAT cTnI test.

Device Story

i-STAT Cardiac Markers Controls consist of three levels of assayed liquid serum containing human cardiac troponin I (cTnl), CK-MB, and myoglobin. Used to verify integrity of newly received i-STAT cTnl cartridges and verify calibration across the reportable range. Supplied as frozen liquid in 1 mL vials; preserved with sodium azide. Used in clinical settings by healthcare professionals to ensure accuracy of i-STAT diagnostic test results. Provides quality assurance for cardiac marker testing; helps maintain diagnostic reliability for patient cardiac assessment.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Human serum-based control material; contains native human cardiac Troponin I, CK-MB, and myoglobin; preserved with sodium azide. Supplied as frozen liquid in 1 mL plastic vials with dropper-tops. No electronic, software, or mechanical components.

Indications for Use

Indicated for use as quality control materials to verify the integrity and accuracy of i-STAT cTnI test cartridges.

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

• More Diagnostics Cardiac Markers Control

Submission Summary (Full Text)

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

A. 510(k) Number: K031873
B. Analyte: Control materials for CKMB, Myoglobin, Troponin I
C. Type of Test: NA
D. Applicant: i-STAT Corporation.

E. Proprietary and Established Names:
i-STAT Cardiac Markers Control Level 1
i-STAT Cardiac Markers Control Level 2
i-STAT Cardiac Markers Control Level 3
i-STAT Cardiac Markers Calibration Verification Control Set

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):
The i-STAT Cardiac Markers Controls are used to verify the integrity of newly received i-STAT cTnI cartridges.
The i-STAT Cardiac Markers Calibration Verification Control Set is used to verify the accuracy of results over the measurement range of the i-STAT cTnI test.
2. Special condition for use statement(s): None
3. Special instrument Requirements: None

H. Device Description:
The i-STAT Cardiac Markers Controls are supplied in tree levels packaged as six vials of one level per box with each vial containing 1 mL of control material. The three levels are each comprised of a different level of cardiac Troponin I, human creatinine kinase-MB isoform CK-MB, and myoglobin (all native forms) derived

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from human cardiac material, prepared in human serum and preserved with sodium azide to inhibit microbial growth. The CK-MB and myoglobin are unassayed components in these materials. Only the cardiac troponin I (cTnI) values will be provided in the value assignment sheets for these products. The controls are provided in frozen liquid form and require no reconstitution.

The Cardiac Markers Calibration Verification Control Set is packaged as a tri-level set, comprised of two vials of each of three levels per box.

# I. Substantial Equivalence Information:

1. Predicate device name(s):

More Diagnostics Cardiac Markers Control (#175)

2. Predicate K number(s): K982845
3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Matrix | Human Serum | Human Serum |
| Preservative | Sodium Azide | Sodium Azide |
| Form | Frozen liquid | Frozen liquid |
| Differences | | |
| Item | Device | Predicate |
| Analytes | CKMB (unassayed)
Myoglobin (unassayed) | CKMB (assayed)
Myoglobin (assayed) |
| Vial | 10 mL plastic vial with dropper-top | Plastic bulb |
| Fill volume | 1 mL | 300 uL |

J. Standard/Guidance Document Referenced (if applicable): None referenced.

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):

The i-STAT Cardiac Marker Controls are each comprised of a different level of cardiac Troponin I, human creatinine kinase – MB isoform CK-

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MB, and myoglobin (all native forms) derived from human cardiac material, and are prepared in human serum.

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:

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

| cTnI | Range |
| --- | --- |
| Level 1 | 0.36-0.67 ng/mL |
| Level 2 | 1.42-2.64 ng/mL |
| Level 3 | 17.70-32.88 ng/mL |

M. Conclusion:

Based on the information provided, I recommend that i-STAT Cardiac Makers Control Level 1, i-STAT Cardiac Markers Control Level 2, i-STAT Cardiac Markers Control Level 3, and i-STAT Cardiac Markers Calibration Verification Control Set are substantially equivalent to the currently marketed product.