Hemochron Signature Elite

K193041 · Accriva Diagnostics, Inc. · JPA · Nov 22, 2019 · Hematology

Device Facts

• Record ID: K193041
• Device Name: Hemochron Signature Elite
• Applicant: Accriva Diagnostics, Inc.
• Product Code: JPA · Hematology
• Decision Date: Nov 22, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Intended Use

The Hemochron™ Signature Elite Whole Blood Microcoagulation System is a battery-operated, hand-held instrument that performs individual point-of-care coagulation tests on fresh or citrated whole blood. These tests include: Activated Clotting Time (ACT+ and ACT-LR), Activated Partial Thromboplastin Time (APTT and APTT Citrate), and Prothrombin Time (PT and PT Citrate). The system is intended to be used with test cuvettes that are available from the manufacturer. For in vitro Diagnostic Use. For professional use. Rx only.

Device Story

Hemochron Signature Elite is a multipurpose system for in vitro coagulation studies. Device modification (v2.3 to v2.4) updates instrument heater control loop to maintain tighter temperature regulation (37±1°C) within cuvette test channel during assay test phase. System operates in clinical settings to provide coagulation monitoring. Healthcare providers use output to assess patient coagulation status and guide clinical decision-making.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing and software verification/validation for the version update.

Technological Characteristics

Multipurpose system for in vitro coagulation studies. Modification involves software-controlled heater plate and cuvette test channel temperature regulation (37±1°C).

Indications for Use

Indicated for professional point-of-care coagulation testing (ACT, APTT, PT) using fresh or citrated whole blood 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

• Hemochron™ Signature Elite (K050016)

Submission Summary (Full Text)

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November 22, 2019

Accriva Diagnostics, Inc. Brian James Sr. Manager, Regulatory Affairs 6260 Sequence Drive San Diego, California 92121

Re: K193041

Trade/Device Name: Hemochron Signature Elite Regulation Number: 21 CFR 864.5425 Regulation Name: Multipurpose System For In Vitro Coagulation Studies Regulatory Class: Class II Product Code: JPA Dated: October 30, 2019 Received: October 31, 2019

Dear Brian James:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Takeesha Taylor-Bell Acting Deputy Director Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

Device Name Hemochron™ Signature Elite

### Indications for Use (Describe)

The Hemochron™ Signature Elite Whole Blood Microcoagulation System is a battery-operated, hand-held instrument that performs individual point-of-care coagulation tests on fresh or citrated whole blood. These tests include: Activated Clotting Time (ACT+ and ACT-LR), Activated Partial Thromboplastin Time (APTT and APTT Citrate), and Prothrombin Time (PT and PT Citrate). The system is intended to be used with test cuvettes that are available from the manufacturer.

For in vitro Diagnostic Use. For professional use. Rx only.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# 510(k) Summary

This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92

| Submitter's Information | Accriva Diagnostics, Inc.<br>6260 Sequence Drive<br>San Diego, CA 92121, USA |
|-------------------------|------------------------------------------------------------------------------|
|-------------------------|------------------------------------------------------------------------------|

| Contact Person | Brian James, Senior Manager, Regulatory Affairs |
|----------------|-------------------------------------------------|
| | Phone: [phone] |
| | Email: [e-mail] |

| Preparation Date | October 30, 2019 |
|------------------|------------------|
|------------------|------------------|

| Device Trade Name | Hemochron™ Signature Elite |
|-------------------|----------------------------|
|-------------------|----------------------------|

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| Regulatory Information | Classification: | Class II |
|------------------------|-----------------|----------------------------------------------------------|
| | Regulation No.: | 21 CFR 864.5425 |
| | Common Name: | System, Multipurpose For In Vitro<br>Coagulation Studies |
| | Panel: | Hematology (81) |
| | Product Code: | JPA |

| Predicate Device | Hemochron™ Signature Elite: K050016 | |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Indications for Use<br>Intended Use | / The Hemochron™ Signature Elite Whole Blood<br>Microcoagulation System is a battery operated, hand-held<br>instrument that performs individual point-of-care<br>coagulation tests on fresh or citrated whole blood. These<br>tests include: Activated Clotting Time (ACT+ and ACT- | |

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| LR), Activated Partial Thromboplastin Time (APTT and<br>APTT Citrate), and Prothrombin Time (PT and PT Citrate). |
|------------------------------------------------------------------------------------------------------------------|
| The system is intended to be used with test cuvettes that are<br>available from the manufacturer. |
| For in vitro Diagnostic Use. For professional use. Rx only. |

| Device Description | The Hemochron™ Signature Elite Whole Blood<br>Microcoagulation System is a battery operated hand-held<br>instrument. The system is intended for use in<br>clinical settings requiring point of care testing. Whole blood<br>test results are displayed as clotting times (in seconds). The<br>instrument also displays correlated Celite® equivalent ACT<br>values, APTT and PT plasma equivalent values, and the<br>PT INR value. |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The Hemochron™ Signature Elite Whole Blood<br>Microcoagulation System contains a test chamber which<br>warms a test cuvette to the required temperature, and it<br>performs all operations to measure the clotting time of a<br>whole blood sample after it is placed in the test cuvette and<br>the test is started by the operator. The front panel contains a<br>keypad with various action keys as well as a number pad.<br>The operator uses the keypad to select a command or enter<br>information. The instrument also includes a barcode scanner<br>for reading of barcode identifications (IDs). |
| | Data management capabilities are included with the<br>instrument. These capabilities include storage of up to 600<br>patient results and 600 quality control results, designation of<br>quality control levels, tagging of test results with date and<br>time, entry of Patient ID and/or Operator ID or Operator<br>PIN and printing of results |

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| Description of Modification | This Special 510(k) is being submitted to update the<br>Hemochron™ Signature Elite software from Version 2.3 to<br>Version 2.4. |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------|
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------|

| Reason Submission Qualifies<br>as Special 510(k) | The submission meets the criteria for a Special 510(k) based<br>on the following: |
|--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| | The proposed change is submitted by the manufacturer legally authorized to market the existing device |
| | Performance data are unnecessary, or if performance data are necessary, well-established methods are available to evaluate the change; and |
| | All performance data necessary to support Substantial Equivalence (SE) can be reviewed in a summary or risk analysis format. |
| | In addition, the changes described in this submission do not introduce: |
| | Changes to indications for use or intended use |
| | Changes to operating principle |
| | Changes to analytical performance claims |
| | Changes to assay algorithms |

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Comparison to Predicate Device (K050016):

The following is a description of the similarities and differences between the predicate device; the currently marketed Hemochron™ Signature Elite (K050016), compared to the subject device, Hemochron™ Signature Elite with updated software Version 2.4, to demonstrate substantial equivalence.

| Instrument<br>Characteristics | Hemochron™ Signature Elite<br>(Predicate Device - K050016) | Hemochron™ Signature Elite<br>(Subject Device) |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | The Hemochron™ Signature Elite Whole<br>Blood Microcoagulation System is a<br>battery-operated, hand-held instrument<br>that performs individual point-of-care<br>coagulation tests on fresh or citrated whole<br>blood. These tests include: Activated<br>Clotting Time (ACT+ and ACT-LR),<br>Activated Partial Thromboplastin Time<br>(APTT and APTT Citrate), and<br>Prothrombin Time (PT and PT Citrate).<br>The system is intended to be used with test<br>cuvettes that are available from the<br>manufacturer.<br><br>For in vitro Diagnostic Use. For<br>professional use. Rx only. | ✓ Substantially Equivalent<br><br>The HemochronTM Signature Elite<br>Whole Blood Microcoagulation<br>System is a battery-operated, hand-<br>held instrument that performs<br>individual point-of-care<br>coagulation tests on fresh or<br>citrated whole blood. These tests<br>include: Activated Clotting Time<br>(ACT+ and ACT-LR), Activated<br>Partial Thromboplastin Time<br>(APTT and APTT Citrate), and<br>Prothrombin Time (PT and PT<br>Citrate). The system is intended to<br>be used with test cuvettes that are<br>available from the manufacturer.<br><br>For in vitro Diagnostic Use. For<br>professional use. Rx only. |
| Assays used | Activated Clotting Time<br>(ACT+ and ACT-LR)<br>Activated Partial Thromboplastin Time<br>(APTT and APTT Citrate)<br>Prothrombin Time<br>(PT and PT Citrate) | ✓ Substantially Equivalent<br><br>Activated Clotting Time<br>(ACT+ and ACT-LR)<br>Activated Partial<br>Thromboplastin Time<br>(APTT and APTT Citrate)<br>Prothrombin Time<br>(PT and PT Citrate) |
| Sample Type | Fresh Whole Blood | ✓ Substantially Equivalent |
| | Citrated Whole Blood | Fresh Whole Blood<br>Citrated Whole Blood |
| Reagents | Supplied in self-contained disposable cuvette | Supplied in self-contained disposable cuvette<br>✓ Substantially Equivalent |
| Reported Results | Celite ACT Equivalent Time – ACT+,<br>ACT-LR<br>International Normalized Ratios (INR) –<br>PT, citrate-PT<br>Whole Blood values - APTT, citrate-APTT,<br>PT, citrate-PT<br>Plasma Equivalent (PE) Values – APTT,<br>citrate-APTT, PT, citrate-PT | Celite ACT Equivalent Time – ACT+,<br>ACT-LR<br>International Normalized Ratios (INR) - PT, citrate-PT<br>Whole Blood values - APTT, citrate-APTT, PT, citrate-PT<br>Plasma Equivalent (PE) Values –<br>APTT, citrate-APTT, PT, citrate-PT<br>✓ Substantially Equivalent |
| Precision | ≤10% C.V. for whole blood samples | ✓ Substantially Equivalent |
| Results | Displayed on LCD screen | ✓ Substantially Equivalent |
| Timing Range | 0 seconds to 1005 seconds | ✓ Substantially Equivalent |
| Operating<br>Environment | 15°C - 30 °C | ✓ Substantially Equivalent<br>15°C - 30 °C |
| Clot detection method | Mechanical-optical clot detection | ✓ Substantially Equivalent |
| Liquid QC<br>Requirement | Two levels – Performed as directed | ✓ Substantially Equivalent |
| Power | Battery or AC operated | ✓ Substantially Equivalent |
| PC Connectivity | RS-232 and Ethernet Ports | ✓ Substantially Equivalent |
| User/Patient Data<br>Input | User keypad or barcode scanner entry | ✓ Substantially Equivalent |
| Data Storage Capacity | 16 OID/20 PID alphanumeric characters<br>600 entries | ✓ Substantially Equivalent |
| Electronic QC<br>Requirement | Internal electronic QC | ✓ Substantially Equivalent |

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| | Assay Parameter Input | User keypad or barcode scanner entry | | Substantially Equivalent |
|-------------|----------------------------|--------------------------------------|---|--------------------------|
| | LQC Parameter Input | User keypad or barcode scanner entry | ✓ | Substantially Equivalent |
| Differences | | | | |
| | Incubation Warm Up<br>Time | 30 seconds to 90 seconds | | Up to 200 seconds |

## Conclusion:

Based on the identical indications for use, operating principle, analytical performance claims, and assay algorithms, the Hemochron™ Signature Elite with software Version 2.4 can be concluded to be substantially equivalent to the cleared and currently marketed predicate device, Hemochron™ Signature Elite (K050016).