GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+), GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR), directCHECK ACT+ Whole Blood Control, Level 1 and Level 2, directCHECK ACT-LR Whole Blood Control, Level 1 and Level 2

K202101 · Accriva Diagnostics, Inc. · JPA · Dec 29, 2021 · Hematology

Device Facts

• Record ID: K202101
• Device Name: GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+), GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR), directCHECK ACT+ Whole Blood Control, Level 1 and Level 2, directCHECK ACT-LR Whole Blood Control, Level 1 and Level 2
• Applicant: Accriva Diagnostics, Inc.
• Product Code: JPA · Hematology
• Decision Date: Dec 29, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Intended Use

The GEM® Hemochron™ 100 System is a battery-operated portable instrument that performs individual in vitro quantitative coagulation tests on fresh whole blood. The system is intended to be used with test cartridges available from the manufacturer and include tests for Activated Clotting Time (ACT+) and Low Range Activated Clotting Time (ACT-LR). The system is intended for use only in point-of-care settings for patients aged 18 years and above. The GEM® Hemochron™ 100 ACT+ (Activated Clotting Time Plus) test is a quantitative assay for monitoring anticoagulation with moderate to high unfractionated heparin (UFH) doses in fresh whole blood samples. This test is intended for monitoring UFH administered during cardiovascular surgery and cardiac ablation procedures. The GEM® Hemochron™ 100 ACT+ demonstrates linear correlation to the anticoagulation effects of UHF concentrations of 1.0 to 6.0 units/mL. The GEM® Hemochron™ 100 ACT-LR (Low Range Activated Clotting Time) test is a quantitative assay for monitoring anticoagulation with low to moderate unfractionated heparin (UFH) doses in fresh whole blood samples. This test is intended for monitoring UFH administered during extracorporeal life support and cardiology procedures. The GEM® Hemochron™ 100 ACT-LR test demonstrates linear correlation to the anticoagulation effects of UFH concentrations up to 2.5 units/mL. For in vitro diagnostic use. For Professional Use, Rx Only.

Device Story

Portable, battery-operated coagulation analyzer for point-of-care use by healthcare professionals. Inputs: fresh whole blood sample applied to single-use disposable cartridge (ACT+ or ACT-LR). Operation: instrument warms cartridge; internal vacuum pump draws blood into test channel; internal camera monitors sample motion; flow reduction below threshold indicates fibrin clot formation; internal timer measures elapsed time. Output: ACT Celite-equivalent value (CEV) in seconds displayed on color touchscreen. Data stored locally (10,000 records) or transmitted via Wi-Fi/Ethernet to HIS/LIS. Benefits: rapid, quantitative anticoagulation monitoring at bedside to guide clinical decision-making during surgery or life support.

Clinical Evidence

Bench testing only. Precision studies (CLSI EP05-A3) performed with liquid controls and donor whole blood samples across multiple lots/instruments. Method comparison (CLSI EP09-A3) against predicate Hemochron Signature Elite using 40 normal subjects (spiked with UFH) showed high correlation (r=0.979 for ACT+, r=0.947 for ACT-LR) and minimal bias at medical decision levels.

Technological Characteristics

Portable coagulation analyzer; opto-mechanical clot detection; thermistor-controlled heating. Connectivity: Wi-Fi (802.11 b/g/n) and Ethernet. Software: Android 7.1. Power: Battery or AC. Cartridges: Single-use, preloaded with dried silica/kaolin/phospholipids/Celite/buffers. 2D barcode identification via internal camera.

Indications for Use

Indicated for patients aged 18+ in point-of-care settings. ACT+ test monitors moderate-to-high UFH doses during cardiovascular surgery and cardiac ablation. ACT-LR test monitors low-to-moderate UFH doses during extracorporeal life support and cardiology procedures.

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 Microcoagulation System (K193041)
• Hemochron™ Activated Clotting Time Plus (ACT+) Test (K941007)
• Hemochron™ Low Range Activated Clotting Time (ACT-LR) Test (K960749)
• directCHECK™ Control for Hemochron Jr. Microcoagulation Systems ACT+ and ACT-LR cuvettes (K120977)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 29, 2021

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

# Re: K202101

Trade/Device Name: GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+), GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR), directCHECK ACT+ Whole Blood Control, Level 1 and Level 2, directCHECK ACT-LR Whole Blood Control, Level 1 and Level 2 Regulation Number: 21 CFR 864.5425 Regulation Name: Multipurpose system for in vitro coagulation studies Regulatory Class: Class II Product Code: JPA, JBP, GGN Dated: July 28, 2020 Received: July 29, 2020

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.

{1}------------------------------------------------

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 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,

Min Wu. Ph.D. Acting Chief 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

{2}------------------------------------------------

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

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known) K202101

### Device Name

GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+), GEM Hemochron 100 Low Range Activated Clotting Time Text (ACT-LR), directCHECK ACT+ Whole Blood Controls, Level 1 and Level 2, directCHECK ACT-LR Whole Blood Controls, Level 1 and Level 2

Indications for Use (Describe)

GEM Hemochron 100 System:

The GEM® Hemochron™ 100 System is a battery-operated portable instrument that performs individual in vitro quantitative coagulation tests on fresh whole blood. The system is intended to be used with test cartridges available from the manufacturer and include tests for Activated Clotting Time (ACT+) and Low Range Activated Clotting Time (ACT-LR). The system is intended for use only in point-of-care settings for patients aged 18 years and above.

The GEM® Hemochron™ 100 ACT+ (Activated Clotting Time Plus) test is a quantitative assay for monitoring anticoagulation with moderate to high unfractionated heparin (UFH) doses in fresh whole blood samples. This test is mended for monitoring UFH administered during cardiovascular surgery and cardiac ablation procedures. The GEM® Hemochron™ 100 ACT+ demonstrates linear correlation to the anticoagulation effects of UFH concentrations of 1.0 to 6.0 units/mL.

The GEM® Hemochron™ 100 ACT-LR (Low Range Activated Clotting Time) test is a quantitative assay for monitoring anticoagulation with low to moderate unfractionated heparin (UFH) doses in fresh whole blood samples. This test is intended for monitoring UFH administered during extracorporeal life support and cardiology procedures. The GEM® Hemochron™ 100 ACT-LR test demonstrates linear correlation to the anticoagulation effects of UFH concentrations up to 2.5 units/mL.

For in vitro diagnostic use. For Professional Use, Rx Only ..

GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+):

The GEM® Hemochron™ 100 ACT+ (Activated Clotting Time Plus) test is a quantitative assay for monitoring . anticoagulation with moderate to high unfractionated heparin (UFH) doses in fresh whole blood samples. This test is intended for monitoring UFH administered during cardiovascular surgery and cardiac ablation procedures. The GEM® Hemochron™ 100 ACT+ demonstrates linear correlation to the anticoagulation effects of UFH concentrations of 1.0 to 6.0 units/mL.

The GEM® Hemochron™ 100 ACT+ test can be performed on the GEM® Hemochron™ 100 System and any model of Hemochron™ Signature Series device. Each instrument is portable, which allows testing at the point-of-care. For in vitro diagnostic use.

For Professional Use, Rx Only

GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR):

The GEM® Hemochron™ 100 ACT-LR (Low Range Activated Clotting Time) test is a quantitative assay for monitoring anticoagulation with low to moderate unfractionated heparin (UFH) doses in fresh whole blood samples. This test is intended for monitoring UFH administered during extracorporeal life support and cardiology procedures. The GEM® Hemochron™ 100 ACT-LR test demonstrates linear correlation effects of UFH concentrations up to 2.5 units/mL.

The GEM Hemochron 100 ACT-LR test can be performed on the GEM® Hemochron™ 100 system and any model of Hemochron™ Signature Series device. Instruments are portable, which allows testing at the point-of-care. For in vitto diagnostic use.

For Professional Use, Rx Only.

{3}------------------------------------------------

directCHECK Whole Blood Controls:

The directCHECK™ Whole Blood Quality Controls are dried whole blood preparations which have been assayed and are intended to be used to perform quality control assays using the Hemochron™ test cartridges

For in vitro Diagnostic Use. For Professional Use, Rx Only.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995,

## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

# 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. This is a Traditional 510(k)

# 1. Sponsor/Application Information and Date [807.92(A)(1)]

| Owner/Manufacturer Name and Address: | Accriva Diagnostics, Inc.<br>6260 Sequence Drive<br>San Diego, CA 92121<br>FEI Number: 2250033<br>Establishment Registration Number: 3002721930 |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Name and Address: | Accriva Diagnostics, Inc.<br>6260 Sequence Drive<br>San Diego, CA 92121<br>FEI Number: 2250033<br>Establishment Registration Number: 3002721930 |
| Contact Person: | Brian James<br>Sr. Manager, Regulatory Affairs<br>Accriva Diagnostics, Inc.<br>[phone]<br>[e-mail] |
| Application Correspondent: | Brian James<br>Sr. Manager, Regulatory Affairs<br>Accriva Diagnostics, Inc.<br>[phone]<br>[e-mail] |
| Date Summary Prepared: | December 24th 2021 |

{5}------------------------------------------------

# 2. Device Name and Classification [807.92 (A)(2)]

| Trade Name | Common Name | Classification Name | Classification | Product Code |
|---------------------------------------------------------------------|--------------------------------|------------------------------------------------------|--------------------------------------|--------------|
| GEM® Hemochron™ 100 System | Coagulation Analyzer | Multipurpose system for in vitro coagulation studies | Class II<br>21 CFR 864.5425 | JPA |
| GEM® Hemochron™ 100 Activated Clotting Time Plus Test (ACT+) | ACT Whole Blood Clotting Assay | Activated whole blood clotting time tests | Class II<br>21 CFR 864.7140 | JBP |
| GEM® Hemochron™ 100 Low Range Activated Clotting Time Test (ACT-LR) | ACT Whole Blood Clotting Assay | Activated whole blood clotting time tests | Class II<br>21 CFR 864.7140 | JBP |
| directCHECK™ ACT+ Whole Blood Controls, Level 1 and Level 2 | Plasma Coagulation Control | Multipurpose system for in vitro coagulation studies | Class II (exempt)<br>21 CFR 864.5425 | GGN |
| directCHECK™ ACT-LR Whole Blood Controls, Level 1 and Level 2 | Plasma Coagulation Control | Multipurpose system for in vitro coagulation studies | Class II (exempt)<br>21 CFR 864.5425 | GGN |

# 3. Identification of Legally Marketed Predicate Device [807.92(A)(3)]

| Trade Name | Predicate Device | Predicate 510(k) Number | Trade Name | Device Description |
|---------------------------------------------------------------------|------------------------------------------------------------------------------------------|-------------------------|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| GEM® Hemochron™ 100 System | Hemochron™ Signature Elite Microcoagulation System | K193041 | GEM® Hemochron™ 100 System | The GEM® Hemochron™ 100 system is a battery-operated, point-of-care coagulation<br>analyzer that represents the next generation platform of the predicate Hemochron™ Signature<br>Elite microcoagulation system. The analyzer employs the same fundamental opto-mechanical<br>clot detection technology and the same analytical algorithms used by the predicate device for<br>calculating test results. The single-use test cartridges for Activated Whole Blood Clotting<br>Time Plus (ACT+) or Low Range ACT (ACT-LR) assays are identical to the cartridges used<br>by the predicate analyzer. Whole Blood Controls used on the GEM® Hemochron™ 100<br>system are identical to those used on the Hemochron™ Signature Elite. The system is<br>intended for use only in clinical settings requiring point of care testing. ACT results for<br>patient blood samples or liquid control material are displayed as ACT Celite-equivalent<br>values (CEV) in seconds.<br>The analyzer contains a test chamber which warms a test cartridge to the required<br>temperature, and it performs all operations to measure the clotting time of a whole blood<br>sample after it is placed in the test cartridge and the test is started by the operator. The user<br>interface includes a color touch screen that displays various action keys and an external<br>barcode scanner for reading Operator identification number (OID), Patient identification<br>(PID) number and lot numbers and expiry dates of liquid quality controls (QC). The operator<br>uses the touch screen to select a command, set software configurations or enter information.<br>The GEM® Hemochron™ 100 system is POCT1-A2 compliant and has Wi-Fi and Ethernet<br>networking capability. It has increased storage for 10,000 patient and QC records. ACT+ and<br>ACT-LR cartridge labels are modified to include a 2D barcode that identifies test type, lot<br>number and expiry date, which is readable by the internal camera. Quality control features<br>such as designation of QC levels, tagging of test results with date and time, and entry of OID<br>and PID numbers are included and are similar to the predicate device.<br>The GEM® Hemochron™ 100 system is intended for use at the point of care professional<br>healthcare environments such as the Cardiovascular Operating Room and Catheterization lab<br>and is designed to perform its essential tasks of performing in-vitro diagnostic blood<br>coagulation-time tests without the use of a network connection. The device contains an<br>802.11 interface which supports WPA2 encryption as well as EAP authentication framework.<br>The device is able to connect to a Wireless Local Area Network (WLAN) via 802.11 b/g/n<br>connections at 2.4 and 5 GHz. The communications interfaces supported by the device are<br>utilized to configure or update the device software by supervisory staff before deployment to<br>the intended use environment and in the reporting of test results to the Laboratory or Hospital |
| GEM® Hemochron™ 100 Activated Clotting Time Plus Test (ACT+) | Hemochron™ Activated Clotting Time Plus (ACT+) Test | K941007 | | |
| GEM® Hemochron™ 100 Low Range Activated Clotting Time Test (ACT-LR) | Hemochron™ Low Range Activated Clotting Time (ACT-LR) Test | K960749 | | |
| directCHECK™ ACT+ Whole Blood Controls, Level 1 and Level 2 | directCHECK™ Control for Hemochron Jr. Microcoagulation Systems ACT+ and ACT-LR cuvettes | K120977 | | |
| directCHECK™ ACT-LR Whole Blood Controls, Level 1 and Level 2 | directCHECK™ Control for Hemochron Jr. Microcoagulation Systems ACT+ and ACT-LR cuvettes | K120977 | | |

{6}------------------------------------------------

# 4. Device Description [807.92 (A)(4)]

{7}------------------------------------------------

Information Systems (LIS/HIS) by the clinical operators at the point of care. Test results are used directly at the point of care in aiding medical decision making, and the device's intended use is not reliant on the device's ability to transmit the information to the LIS/HIS.

This instrument complies with the requirements of FCC Part 15 Subpart B, Innovation, Science and Economic Development Canada (ISED) ICES-003, and EN 61326-1:2013 as shown below:

| FCC ID: | 2AQV3-GEM100 |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IC Certificate: | 24216-GEM100 |
| Product Name: | GEM Hemochron 100 |
| Model(s): | GEM100 |
| Equipment Type: | Wireless Handheld Hemochron |
| Classification: | Portable Transmitter Handheld Only |
| TX Frequency Range: | 2412-2462 MHz; 5180-5320 MHz; 5500-5700 MHz; 5745-<br>5825 MHz |
| Frequency Tolerance: | ±2.5 ppm |
| Maximum RF Output: | 2450 MHz (b) -15.50 dB, 2450 MHz (g) – 19.00 dB, 2450 MHz (n) - 21.50 dB,<br>5250 MHz (a) – 16.00 dB, 5250 MHz (n) – 16.00 dB, 5600 MHz (a) - 17.50 dB,<br>5600 MHz (n) – 17.50 dB, 5800 MHz (a) – 17.00 dB, 5800 MHz (n) - 17.00 dB Conducted |
| Signal Modulation: | DSSS, OFDM |
| Antenna Type: | Internal; PIFA Antenna |
| FCC Rule Parts: | Part 2, 15C, 15E |
| KDB Test Methodology: | KDB 447498 D01 v06, KDB 248227 v02r02, KDB 616217<br>D04 v01r02 |
| Industry Canada: | RSS-102 Issue 5, Safety Code 6 |
| Maximum SAR Value: | 1.02 W/kg Reported 10 Gram Average |
| Maximum Simultaneous SAR: | 1.45 W/kg Reported 10 Gram Average |
| Separation Distance: | 0 mm |

The GEM Hemochron 100 utilizes the following list of wireless technologies:

| Band | Technology | 3GPP<br>Nominal<br>Power<br>dBm | Setpoint<br>Nominal<br>Power<br>dBm | Tolerance<br>dBm | Lower<br>Tolerance<br>dBm | Upper<br>Tolerance<br>dBm | |
|-----------------------------------|-------------------------------------------------------------------------------------------------|---------------------------------|-------------------------------------|------------------|---------------------------|---------------------------|------|
| WLAN -<br>2.4 GHz | 802.11b | N/A | 13.5 | $\pm2$ | 11.5 | 15.5 | |
| WLAN -<br>2.4 GHz | 802.11g | N/A | 17.0 | $\pm2$ | 15.0 | 19.0 | |
| WLAN -<br>2.4 GHz | 802.11n | N/A | 19.5 | $\pm2$ | 17.5 | 21.5 | |
| WLAN -<br>5 GHz<br>Band I,<br>IIA | 802.11a<br>(36-56) | N/A | 13.0 | $\pm2$ | 11.0 | 15.0 | |
| | WLAN –<br>5 GHz<br>Band IIA | 802.11a<br>(60-64) | N/A | 14.0 | $\pm$ 2 | 12.0 | 16.0 |
| | WLAN –<br>5 GHz<br>Band I,<br>IIA | 802.11n<br>(36-56) | N/A | 13.0 | $\pm$ 2 | 11.0 | 15.0 |
| | WLAN –<br>5 GHz<br>Band IIA | 802.11n<br>(60-64) | N/A | 14.0 | $\pm$ 2 | 12.0 | 16.0 |
| | WLAN –<br>5 GHz<br>Band IIC | 802.11a | N/A | 15.5 | $\pm$ 2 | 13.5 | 17.5 |
| | WLAN –<br>5 GHz<br>Band IIC | 802.11n | N/A | 15.5 | $\pm$ 2 | 13.5 | 17.5 |
| | WLAN –<br>5 GHz<br>Band III | 802.11a | N/A | 15.0 | $\pm$ 2 | 13.0 | 17.0 |
| | WLAN –<br>5 GHz<br>Band III | 802.11n | N/A | 15.0 | $\pm$ 2 | 13.0 | 17.0 |
| GEM® | GEM® Hemochron™ 100 ACT+ cartridges are single-use disposable test devices with a well | | | | | | |
| Hemochron™ | for application of liquid QC and whole blood samples. When a liquid QC or patient test is | | | | | | |
| 100 Activated | requested, the instrument prompts the Operator to insert a cartridge into the instrument. After | | | | | | |
| Clotting Time | the instrument warms the cartridge, it prompts the Operator to apply the sample into the | | | | | | |
| Plus Test | sample well of the cartridge. | | | | | | |
| (ACT+) | The ACT+ test cartridge is a self-contained disposable test chamber preloaded with a dried | | | | | | |
| | preparation of silica, kaolin, phospholipid, stabilizers, and buffers that provide maximum | | | | | | |
| | activation as defined by clinical practice guidelines. Each cartridge is sealed in a foil pouch | | | | | | |
| | labeled with lot number and expiry date. | | | | | | |
| | Reagents in GEM® Hemochron™ 100 ACT+ cartridges (000GACT+) are identical in | | | | | | |
| | composition to those in the predicate Hemochron™ ACT+ cuvettes (JACT-LR). A 2D | | | | | | |
| | barcode added to the cartridge label identifies the test type, lot number and expiry date. This | | | | | | |
| | information is automatically read by the internal camera. | | | | | | |
| | Each box of GEM® Hemochron™ 100 ACT+ cartridges contain 45 pouches, each pouch | | | | | | |
| | containing one GEM® Hemochron™ 100 ACT+ cartridge and one desiccant packet. | | | | | | |
| GEM® | GEM® Hemochron™ cartridges are single-use disposable test devices with wells for | | | | | | |
| Hemochron™ | application of samples. When a patient test or an LQC test is requested, the instrument | | | | | | |
| 100 Low Range | prompts the Operator to insert a cartridge into the instrument. After the instrument warms the | | | | | | |
| Activated | cartridge, it prompts the Operator to apply the sample into the sample well of the cartridge. | | | | | | |
| Clotting Time | Each GEM® Hemochron™ 100 ACT-LR cartridge is sealed in a foil pouch labeled with lot | | | | | | |

{8}------------------------------------------------

{9}------------------------------------------------

| Test (ACT-LR) | number and expiry date. The cartridge is a self-contained disposable test chamber preloaded<br>with a dried preparation of Celite and silicon dioxide activators, potato dextrin, stabilizers,<br>and buffers to provide maximum activation as defined by clinical practice guidelines. |
|----------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Reagents in GEM® Hemochron™ 100 ACT-LR cartridges (000GACT-LR) are identical in composition to those in the predicate Hemochron™ ACT-LR cuvettes (JACT-LR). A 2D barcode added to the cartridge label identifies the test type, lot number and expiry date. This information is automatically read by a new internal camera. |
| | Each box of GEM® Hemochron™ 100 ACT-LR cartridges contain 45 pouches, each pouch containing one GEM® Hemochron™ 100 ACT-LR cartridge and one desiccant. |
| directCHECK™<br>Whole Blood<br>Quality<br>Controls, Level<br>1 and Level 2 | Blood coagulation instruments and assays should be quality controlled prior to and during routine use. Performance ranges are provided with each control product against which users should compare results. Quality assurance programs include instrument service, quality control and complete performance records. |
| | directCHECK™ Quality Control products are to be used with Hemochron Systems (GEM® Hemochron™ 100 and Hemochron™ Signature Series). Level 1 and Level 2 QC products are provided in separate packaging. These preparations consist of dried fixed bovine red blood cells, rabbit cephalin, buffered sheep and horse plasma. Assayed clotting time values are provided with each lot of material. |
| | Each control preparation is provided in a dropper vial. Each dropper vial also contains diluent used to rehydrate the dried whole blood control. Diluent preparations consist of distilled water, sodium chloride, Tween® 20, ProClin®, and anticoagulant. |

# 5. Intended Use [807.92(A)(5)]

| Trade Name | Intended Use/Indications for Use |
|-------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| GEM® Hemochron™ 100 System | The GEM® Hemochron™ 100 System is a battery-operated portable instrument that performs individual in vitro quantitative coagulation tests on fresh whole blood. The system is intended to be used with test cartridges available from the manufacturer and include tests for Activated Clotting Time (ACT+) and Low Range Activated Clotting Time (ACT-LR). The system is intended for use only in point-of-care settings for patients aged 18 years and above. |
| The GEM® Hemochron™ 100 ACT+ (Activated Clotting Time Plus) test | The GEM® Hemochron™ 100 ACT+ (Activated Clotting Time Plus) test is a quantitative assay for monitoring anticoagulation with moderate to high unfractionated heparin (UFH) doses in fresh whole blood samples. This test is intended for monitoring UFH administered during cardiovascular surgery and cardiac ablation procedures. The GEM® Hemochron™ 100 ACT+ demonstrates linear correlation to the anticoagulation effects of UFH concentrations of 1.0 to 6.0 units/mL. |
| | The GEM® Hemochron™ 100 ACT-LR (Low Range Activated Clotting Time) test is a<br>quantitative assay for monitoring anticoagulation with low to moderate unfractionated<br>heparin (UFH) doses in fresh whole blood samples. This test is intended for monitoring<br>UFH administered during extracorporeal life support and cardiology procedures. The<br>GEM® Hemochron™ 100 ACT-LR test demonstrates linear correlation to the<br>anticoagulation effects of UFH concentrations up to 2.5 units/mL.<br>For <i>in vitro</i> diagnostic use. For Professional Use, Rx Only. |
| GEM® Hemochron™<br>100 Activated Clotting<br>Time Plus Test (ACT+) | The GEM® Hemochron™ 100 ACT+ (Activated Clotting Time Plus) test is a<br>quantitative assay for monitoring anticoagulation with moderate to high unfractionated<br>heparin (UFH) doses in fresh whole blood samples. This test is intended for monitoring<br>UFH administered during cardiovascular surgery and cardiac ablation procedures. The<br>GEM® Hemochron™ 100 ACT+ demonstrates linear correlation to the anticoagulation<br>effects of UFH concentrations of 1.0 to 6.0 units/mL.<br>The GEM® Hemochron™ 100 ACT+ test can be performed on the GEM® Hemochron™ |
| | 100 System and any model of Hemochron™ Signature Series device. Each instrument is<br>portable, which allows testing at the point-of-care. For <i>in vitro</i> diagnostic use. For<br>Professional Use, Rx Only. |
| GEM® Hemochron™<br>100 Low Range Activated<br>Clotting Time Test (ACT-<br>LR) | The GEM® Hemochron™ 100 ACT-LR (Low Range Activated Clotting Time) test is a<br>quantitative assay for monitoring anticoagulation with low to moderate unfractionated<br>heparin (UFH) doses in fresh whole blood samples. This test is intended for monitoring<br>UFH administered during extracorporeal life support and cardiology procedures. The<br>GEM® Hemochron™ 100 ACT-LR test demonstrates linear correlation to the<br>anticoagulation effects of UFH concentrations up to 2.5 units/mL. |
| | The GEM Hemochron 100 ACT-LR test can be performed on the GEM® Hemochron™<br>100 system and any model of Hemochron™ Signature Series device. Instruments are<br>portable, which allows testing at the point-of-care. For <i>in vitro</i> diagnostic use. For<br>Professional Use, Rx Only. |
| directCHECK™ Whole<br>Blood Quality Controls,<br>Level 1 and Level 2 | The directCHECK™ Whole Blood Quality Controls are dried whole blood preparations<br>which have been assayed and are intended to be used to perform quality control assays<br>using the Hemochron™ test cartridges. For <i>in vitro</i> Diagnostic Use. For Professional Use,<br>Rx Only. |

{10}------------------------------------------------

{11}------------------------------------------------

#### Technological Similarities and Differences to the Predicate [807.92 (A)(6)] 6.

The following is a description of the similarities and differences between the predicate device; the currently marketed Hemochron™ Signature Elite (K193041), compared to the subject device, GEM® Hemochron™ 100 System, to demonstrate substantial equivalence.

| Instrument<br>Characteristics | Hemochron™ Signature Elite<br>(Predicate Device – K193041) | GEM® Hemochron™ 100 System<br>(Subject Device) |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Similarities | |
| Intended Use | The Hemochron™ Signature Elite Whole<br>Blood Microcoagulation System is a battery-<br>operated, hand-held instrument that performs<br>individual point-of-care coagulation tests on<br>fresh or citrated whole blood. These tests<br>include: Activated Clotting Time (ACT+ and<br>ACT-LR), Activated Partial Thromboplastin<br>Time (APTT and APTT Citrate), and<br>Prothrombin Time (PT and PT Citrate). The<br>system is intended to be used with test cuvettes<br>that are available from the manufacturer.<br>For <i>in vitro</i> Diagnostic Use. For professional<br>use. Rx only. | ✓ Substantially Equivalent<br>The GEM® Hemochron™ 100 System is a<br>battery-operated portable instrument that<br>performs individual <i>in vitro</i> quantitative<br>coagulation tests on fresh whole blood. The<br>system is intended to be used with test cartridges<br>available from the manufacturer and include<br>tests for Activated Clotting Time (ACT+) and<br>Low Range Activated Clotting Time (ACT-LR).<br>The system is intended for use only in point-of-<br>care settings for patients aged 18 years and<br>above.<br><br>The GEM® Hemochron™ 100 ACT+<br>(Activated Clotting Time Plus) test is a<br>quantitative assay for monitoring<br>anticoagulation with moderate to high<br>unfractionated heparin (UFH) doses in fresh<br>whole blood samples. This test is intended for<br>monitoring UFH administered during<br>cardiovascular surgery and cardiac ablation<br>procedures. The GEM® Hemochron™ 100<br>ACT+ demonstrates linear correlation to the<br>anticoagulation effects of UFH concentrations<br>of 1.0 to 6.0 units/mL.<br><br>The GEM® Hemochron™ 100 ACT-LR (Low<br>Range Activated Clotting Time) test is a<br>quantitative assay for monitoring<br>anticoagulation with low to moderate<br>unfractionated heparin (UFH) doses in fresh<br>whole blood samples. This test is intended for<br>monitoring UFH administered during<br>extracorporeal life support and cardiology<br>procedures. The GEM® Hemochron™ 100<br>ACT-LR test demonstrates linear correlation to<br>the anticoagulation effects of UFH |
| | | For in vitro diagnostic use. For Professional<br>Use, Rx Only. |
| Assays Used | Activated Clotting Time<br>(ACT+ and ACT-LR)<br>Activated Partial Thromboplastin Time (APTT<br>and APTT Citrate)<br>Prothrombin Time<br>(PT and citrate-PT) | ✓ Substantially Equivalent<br>Activated Clotting Time<br>(ACT+ and ACT-LR) only |
| Sample Type | Fresh Whole Blood | ✓ Substantially Equivalent<br> |
| Reagents | Citrated Whole Blood<br>Supplied in self-contained disposable cuvettes | Fresh Whole Blood only<br>✓ Substantially Equivalent<br>Supplied in self-contained disposable cartridges<br>(cuvettes) |
| Reported Results | Celite ACT Equivalent Time – ACT+ and<br>ACT-LR<br>PT, citrate-PT (INR)<br>Whole Blood Values – APTT, citrate-APTT,<br>PT, citrate-PT<br>Plasma Equivalent (PE) Values – APTT,<br>citrate-APTT, PT, citrate-PT | ✓ Substantially Equivalent<br>ACT Celite-equivalent value (CEV) in seconds<br>– ACT+ and ACT-LR…