I-STAT ACTIVATED CLOTTING TIME (ACT) CONTROL SET LEVEL 1 AND LEVEL 2, MODELS 07G82-01, 07G82-02

K071319 · Bio-Rad, Diagnostics Grp. · GGN · Jun 26, 2007 · Hematology

Device Facts

• Record ID: K071319
• Device Name: I-STAT ACTIVATED CLOTTING TIME (ACT) CONTROL SET LEVEL 1 AND LEVEL 2, MODELS 07G82-01, 07G82-02
• Applicant: Bio-Rad, Diagnostics Grp.
• Product Code: GGN · Hematology
• Decision Date: Jun 26, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Indications for Use

i-STAT Activated Clotting Time (ACT) Control is used to verify the integrity of newly received i-STAT Activated Clotting Time cartridges.

Device Story

The i-STAT Activated Clotting Time (ACT) Control Set is a lyophilized human plasma-based product used for quality control. It is designed to verify the integrity of newly received i-STAT ACT cartridges before clinical use. The control is reconstituted and applied to the cartridge; the i-STAT system then processes the sample to ensure the cartridge is functioning correctly. This process allows healthcare providers to confirm the reliability of coagulation testing results, ensuring accurate clinical decision-making regarding patient anticoagulation status. The device is intended for use by clinical laboratory personnel or healthcare professionals in point-of-care or clinical settings.

Clinical Evidence

No clinical data. Bench testing only. Stability studies conducted on three experimental lots over 18 months at 2-8°C demonstrated analyte results within ±10% deviation of reference values stored at -70°C. Precision data (mean, SD, CV) provided for both levels across three lots, confirming recovery within target ranges (150-250s for Level 1; 450-650s for Level 2).

Technological Characteristics

Lyophilized human plasma control. Reconstituted for use. Storage at 2 to 8°C. No electronic or software components; purely a chemical/biological control reagent.

Indications for Use

Indicated for use as a quality control material to verify the integrity of i-STAT Activated Clotting Time cartridges. Intended for professional use in clinical settings.

Regulatory Classification

Identification

A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.

Special Controls

*Classification.* Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

Predicate Devices

• i-STAT Coagulation Control Set (K981752)

Submission Summary (Full Text)

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

A. 510(k) Number:
K071319

B. Purpose for Submission:
To seek clearance for the i-STAT Activated Clotting Time (ACT) Control Set

C. Measurand:
Activated Clotting Time (ACT)

D. Type of Test:
Quality Control Material

E. Applicant:
Bio-Rad Laboratories

F. Proprietary and Established Names:
- i-STAT Activated Clotting Time (ACT) Control Set Level 1, Model Number 07G82-01
- i-STAT Activated Clotting Time (ACT) Control Set Level 2, Model Number 07G82-02

G. Regulatory Information:
1. Regulation section:
21 CFR 864.5425
2. Classification:
II
3. Product code:
GGN

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4. Panel:
Hematology

H. Intended Use:

1. Intended use(s):
i-STAT Activated Clotting Time (ACT) Control Set is used to verify the integrity of newly received i-STAT Activated Clotting Time cartridges.

2. Indication(s) for use:
i-STAT Activated Clotting Time (ACT) Control Set is used to verify the integrity of newly received i-STAT Activated Clotting Time cartridges.

3. Special conditions for use statement(s):

4. Special instrument requirements:

I. Device Description:

The control set consists of bi-level human plasma, with added purified biochemicals and preservatives. It is provided in lyophilized form for increased stability. $\mathrm{CaCl}_2$ is the reconstituting solution.

The controls are used to verify the integrity of newly received i-STAT ACT cartridges: Kaolin ACT test (K023582) and Celite ACT test (K992571) for the instruments: i-STAT 200 Portable Clinical Analyzer (K940918) and i-STAT Model 200 Portable Clinical Analyzer (K001154).

J. Substantial Equivalence Information:

1. Predicate device name(s):
i-STAT Coagulation Control Set

2. Predicate $510(\mathrm{k})$ number(s):
K981752

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3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device: Bio-Rad i-STAT Activated Clotting Time (ACT) Control Set | Predicate: Biopool Intl., Inc. i-STAT Coagulation Control Set |
| Intended Use | i-STAT Activated Clotting Time (ACT) Control Set is used to verify the integrity of newly received i-STAT Activated Clotting Time cartridges | Same |
| Matrix | Human plasma | Same |
| Form | Lyophilized | Same |
| Open vial stability | Use immediately | Same |
| Differences | | |
| --- | --- | --- |
| Item | Device: Bio-Rad i-STAT Activated Clotting Time (ACT) Control Set | Predicate: Biopool Intl., Inc. i-STAT Coagulation Control Set |
| Storage | Refrigerated (2-8°C) | Refrigerated (2-10°C) |

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

L. Test Principle:

The use of ACT Control Set, levels 1 and 2, is indicated as an objective assessment of the precision of methods and techniques in use and is an integral part of good laboratory practices.

M. Performance Characteristics (if/when applicable):

1. Analytical performance: N/A

a. Precision/Reproducibility:

b. Linearity/assay reportable range:

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

- Shelf life stability: stability studies were performed to determine shelf life for these controls. Product claim for shelf life is 18 months at 2-8°C.

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Real Time Stability Testing: The Activated Clotting Time (ACT) Control Set stability was determined by storing the product under the recommended storage conditions (2-8°C) for the life of the product. These studies were conducted for three experimental lots (E-lots). Several vials of each level were tested at each time point and the results of the real time stabilities samples were compared to the results of reference vials stored at -70°C (Pseudo-T₀). Failure was assumed to have taken place when the product's analyte results had changed by greater than or equal to the established acceptance criteria, ±10% deviation of the reference values.

| Real Time Stability Studies - Activated Clotting Time (ACT) Control Set | | | | |
| --- | --- | --- | --- | --- |
| | | E - lot 1 | E - lot 2 | E - lot 3 |
| | | Day 549 | Day 531 | Day 510 |
| Level 1 | Real time sample | 221 sec. | 239 sec. | 251 sec. |
| | Pseudo-T₀ samples | 220 sec. | 233 sec. | 251 sec. |
| | Deviation of the reference value | 0.46% | 2.43% | 0.00% |
| Level 2 | Real time sample | 719 sec. | 544 sec. | 648 sec. |
| | Pseudo-T₀ samples | 701 sec. | 543 sec. | 636 sec. |
| | Deviation of the reference value | 2.52% | 0.18% | 1.89% |
| Acceptance Criteria | | ± 10% deviation of the reference values | | |

- Open vial stability: there is no open vial claim for this product. The package insert provides the instruction to indicate that the "control solution must be used immediately (less than 30 seconds) after completing the reconstitution and mixing steps."

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

2. Comparison studies: N/A

a. Method comparison with predicate device:
b. Matrix comparison:

3. Clinical studies: N/A

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

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4. Clinical cut-off: N/A
5. Expected values/Reference range:

The i-STAT Activated Clotting Time (ACT) Control Set recovery results for three experimental lots show that the products met targeted activated clotting time.

| Results for Activated Clotting Time (ACT) Control Set | | | |
| --- | --- | --- | --- |
| | | Level 1 | Level 2 |
| Target Range | | 150-250 ACT (seconds) | 450-650 (seconds) |
| E - lot 1 | N | 12 | 12 |
| | Mean | 205 | 626 |
| | SD | 7.3 | 35.1 |
| | CV | 3.58% | 5.62% |
| E - lot 2 | N | 12 | 12 |
| | Mean | 224 | 491 |
| | SD | 11.7 | 15.1 |
| | CV | 5.23% | 3.08% |
| E - lot 3 | N | 12 | 12 |
| | Mean | 234 | 564 |
| | SD | 3.3 | 10.5 |
| | CV | 1.42% | 1.87% |

Accompanying value assignment sheet displays target values and ranges.

N. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

O. Conclusion:

1. The submitted information in this premarket notification is complete and supports a substantial equivalence decision.