HEPARINASE HR ACT CONTROL, MODEL 550-12

K042175 · Medtronic Vascular · GGN · Oct 18, 2004 · Hematology

Device Facts

• Record ID: K042175
• Device Name: HEPARINASE HR ACT CONTROL, MODEL 550-12
• Applicant: Medtronic Vascular
• Product Code: GGN · Hematology
• Decision Date: Oct 18, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Indications for Use

To verify the performance of the ACT instrument and the Heparinase (HR HTC) cartridges

Device Story

CLOTtrac® HTC Control is an in vitro diagnostic device used to verify performance of ACT (Automated Coagulation Timer) instruments and Heparinase (HR HTC) cartridges. Device functions as a quality control material; ensures accuracy of coagulation testing. Used in clinical settings by healthcare professionals. Output provides verification of instrument and cartridge functionality; assists in maintaining quality assurance for coagulation monitoring.

Clinical Evidence

Bench testing only; validation testing performed to establish performance characteristics of modifications relative to the predicate device.

Technological Characteristics

Lyophilized control material; composition: citrated sheep plasma, stabilized sheep erythrocytes, USP porcine heparin. Reconstituted to 6 U/mL. Designed for use with ACT instrumentation and HR-HTC cartridges. Stability: 2 hours at 15°-25° C post-reconstitution. Storage: 2°-10° C. Risk management per ISO 14971.

Indications for Use

Indicated for verifying the performance of the ACT instrument and Heparinase (HR HTC) cartridges.

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

• Medtronic, Inc. (HemoTec, Inc.) CLOTtrac® Heparinase Control (K902081)

Submission Summary (Full Text)

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

A. 510(k) Number:
#K042175

B. Purpose for Submission:
Device modification (Special 510k)

C. Analyte:
Heparin

D. Type of Test:
Quantitative

E. Applicant:
Medtronic Perfusion Systems

F. Proprietary and Established Names:
Medtronic CLOTtrac® HTC Coagulation Control; Coagulation Control Plasma

G. Regulatory Information:
1. Regulation section:
864.5425 – Multipurpose System for in vitro Coagulation Studies
2. Classification:
Class II
3. Product Code:
GGN; JBP
4. Panel:
Hematology (81)

H. Intended Use:
1. Intended use(s):
The Medtronic CLOTtrac® HTC Coagulation Control is for in vitro
diagnostic use to verify performance of the ACT instrument and Heparinase
HR-HTC cartridges.
2. Indication(s) for use:
Same as the Intended Use.
3. Special condition for use statement(s):
N/A
4. Special instrument Requirements:
Activated Clot Timer (ACT) instrumentation.

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I. Device Description:
The CLOTtrac® HTC Coagulation Control is being modified to replace USP bovine heparin with USP porcine heparin. It consists of citrated sheep plasma, and stabilized sheep erythrocytes that are lyophilized and heparinized with USP porcine heparin. It is reconstituted to 6 U/ml with reagent grade water, and used as a fresh whole blood sample.

J. Substantial Equivalence Information:
1. Predicate device name(s):
Medtronic, Inc. (HemoTec, Inc.) CLOTtrac® Heparinase Control
2. Predicate K number(s):
#K902081
3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | To verify performance of the CLOTtrac® Heparinase Cartridge and ACT instrument | Same |
| Instrumentation | Automated Coagulation Timer (ACT) | Same |
| Heparin concentration | 6 Units/mL | Same |
| Stability (reconstituted) | 2 hours at 15°-25° C. | Same |
| Expected results in channel clot time | 90 – 150 seconds | Same |
| Storage (type and temperature) | Lyophilized; 2°-10° C. | Same |
| Differences | | |
| Item | Device | Predicate |
| Heparin type | Porcine | Bovine |

K. Standard/Guidance Document Referenced (if applicable):
ISO14971 – Medical Devices-Application of Risk Management to Medical Devices.

L. Test Principle:
The ACT instrument utilizes HR-HTC cartridges to generate an activated clotting time (ACT) in response to the heparin concentration in a whole blood sample. The

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CLOTtrac® HTC Coagulation Control is designed to verify Channels 1 and 2 of the test cartridges.

## M. Performance Characteristics (if/when applicable):

### 1. Analytical performance:

**a. Precision/Reproducibility:**
Three lots of control were used to test cartridges (N=59) on the ACT instrument. Mean clot times for each lot, in Channel 1, were 106, 111 and 111 seconds, respectively. Within-lot precision, for each lot, was 3.4%, 4.2% and 4.1% CV, respectively.

Channel 2 generated expected clot times of > 999 seconds; except for 8% of controls that generated clot times of < 999 seconds.

**b. Linearity/assay reportable range:**
N/A

**c. Traceability (controls, calibrators, or method):**
The activated clotting time (ACT) method.

**d. Detection limit:**
N/A

**e. Analytical specificity:**
N/A

**f. Assay cut-off:**
N/A

### 2. Comparison studies:

**a. Method comparison with predicate device:**
N/A

**b. Matrix comparison:**
N/A

### 3. Clinical studies:

**a. Clinical sensitivity:**
N/A

**b. Clinical specificity:**
N/A

**c. Other clinical supportive data (when a and b are not applicable):**
N/A

### 4. Clinical cut-off:
N/A

### 5. Expected values/Reference range:
Channel 1 = 90 – 150 seconds; Channel 2 = > 999 seconds

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N. Conclusion:
The submitted material in this premarket notification is complete and supports a substantial equivalence decision.

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