(518 days)
Not Found
No
The description explicitly states the device employs the "same fundamental opto-mechanical clot detection technology and the same analytical algorithms used by the predicate device". There is no mention of AI or ML.
No.
This device is an in vitro diagnostic device used for monitoring anticoagulation; it does not directly treat or prevent a disease or condition in a patient.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use." The device also performs quantitative coagulation tests on fresh whole blood to monitor anticoagulation, which is a diagnostic purpose.
No
The device is described as a "battery-operated portable instrument" and a "coagulation analyzer" that uses "opto-mechanical clot detection technology" and "single-use test cartridges." This clearly indicates the presence of hardware components beyond just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The text explicitly states "For in vitro diagnostic use" multiple times for the system, the ACT+ test, the ACT-LR test, and the directCHECK Whole Blood Controls.
- Intended Use: The intended use describes the system as performing "individual in vitro quantitative coagulation tests on fresh whole blood." This clearly indicates testing performed outside of the body on biological samples.
- Device Description: The device description further reinforces this by stating it is a "point-of-care coagulation analyzer" and is designed to perform "in-vitro diagnostic blood coagulation-time tests."
- Components: The system utilizes test cartridges and controls, which are also explicitly labeled for "in vitro diagnostic use."
Therefore, based on the provided text, the GEM® Hemochron™ 100 System and its associated components are intended for and described as In Vitro Diagnostic devices.
N/A
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 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
JPA, JBP, GGN
Device Description
The GEM® Hemochron™ 100 system is a battery-operated, point-of-care coagulation analyzer that represents the next generation platform of the predicate Hemochron™ Signature Elite microcoagulation system. The analyzer employs the same fundamental opto-mechanical clot detection technology and the same analytical algorithms used by the predicate device for calculating test results. The single-use test cartridges for Activated Whole Blood Clotting Time Plus (ACT+) or Low Range ACT (ACT-LR) assays are identical to the cartridges used by the predicate analyzer. Whole Blood Controls used on the GEM® Hemochron™ 100 system are identical to those used on the Hemochron™ Signature Elite. The system is intended for use only in clinical settings requiring point of care testing. ACT results for patient blood samples or liquid control material are displayed as ACT Celite-equivalent values (CEV) in seconds.
The analyzer contains a test chamber which warms a test cartridge to the required temperature, and it performs all operations to measure the clotting time of a whole blood sample after it is placed in the test cartridge and the test is started by the operator. The user interface includes a color touch screen that displays various action keys and an external barcode scanner for reading Operator identification number (OID), Patient identification (PID) number and lot numbers and expiry dates of liquid quality controls (QC). The operator uses the touch screen to select a command, set software configurations or enter information.
The GEM® Hemochron™ 100 system is POCT1-A2 compliant and has Wi-Fi and Ethernet networking capability. It has increased storage for 10,000 patient and QC records. ACT+ and ACT-LR cartridge labels are modified to include a 2D barcode that identifies test type, lot number and expiry date, which is readable by the internal camera. Quality control features such as designation of QC levels, tagging of test results with date and time, and entry of OID and PID numbers are included and are similar to the predicate device.
The GEM® Hemochron™ 100 system is intended for use at the point of care professional healthcare environments such as the Cardiovascular Operating Room and Catheterization lab and is designed to perform its essential tasks of performing in-vitro diagnostic blood coagulation-time tests without the use of a network connection. The device contains an 802.11 interface which supports WPA2 encryption as well as EAP authentication framework. The device is able to connect to a Wireless Local Area Network (WLAN) via 802.11 b/g/n connections at 2.4 and 5 GHz. The communications interfaces supported by the device are utilized to configure or update the device software by supervisory staff before deployment to the intended use environment and in the reporting of test results to the Laboratory or Hospital 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.
GEM® Hemochron™ 100 ACT+ cartridges are single-use disposable test devices with a well for application of liquid QC and whole blood samples. When a liquid QC or patient test is requested, the instrument prompts the Operator to insert a cartridge into the instrument. After the instrument warms the cartridge, it prompts the Operator to apply the sample into the sample well of the cartridge.
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® Hemochron™ cartridges are single-use disposable test devices with wells for application of samples. When a patient test or an LQC test is requested, the instrument prompts the Operator to insert a cartridge into the instrument. After the instrument warms the cartridge, it prompts the Operator to apply the sample into the sample well of the cartridge.
Each GEM® Hemochron™ 100 ACT-LR cartridge is sealed in a foil pouch labeled with lot number and expiry date. The cartridge is a self-contained disposable test chamber preloaded with a dried preparation of Celite and silicon dioxide activators, potato dextrin, stabilizers, 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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
18 years and above
Intended User / Care Setting
Professional Use / point-of-care settings
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision - Liquid Quality Controls (Celite Equivalent Seconds):
LQC samples were tested in accordance with CLSI EP05-A3 with a test design of 1 site, 20 days (non-sequential), 2 runs per day, and 2 replicates per run, across 2 GEM® Hemochron™ 100 ACT+ and ACT-LR cartridge lots using the GEM® Hemochron™ 100 System
GEM® Hemochron™ 100 ACT+ (N=640 samples for each level)
- Level 1: Mean(s) 157.7, SD 11.4, %CV 7.2%
- Level 2: Mean(s) 419.0, SD 9.7, %CV 2.3%
GEM® Hemochron™ 100 ACT-LR (N=640 samples for each level)
- Level 1: Mean(s) 117.1, SD 10.5, %CV 9.0%
- Level 2: Mean(s) 272.3, SD 19.1, %CV 7.0%
Precision - Donor whole blood samples (Celite Equivalent Seconds):
The study design included a total of 20 test replicates per donor sample (e.g. 2 operators x 5 instruments per operator x 2 test results per instrument).
GEM® Hemochron™ 100 ACT+ (N=20 for each range, N=19 for >=721)
- 68-180: Mean(s) 105.9, Within-instrument SD 5.6, %CV 5.3%
- 181-360: Mean(s) 235.6, Within-instrument SD 22.3, %CV 9.5%
- 361-540: Mean(s) 375.7, Within-instrument SD 6.6, %CV 1.8%
- 541-720: Mean(s) 708.3, Within-instrument SD 41.3, %CV 5.8%
-
=721: Mean(s) 760.1, Within-instrument SD 69.3, %CV 9.1%
GEM® Hemochron™ 100 ACT-LR (N=20 for each range)
- 65-145: Mean(s) 117.5, Within-instrument SD 5.9, %CV 5.0%
- 146-226: Mean(s) 209.8, Within-instrument SD 10.9, %CV 5.2%
- 227-307: Mean(s) 266.8, Within-instrument SD 12.5, %CV 4.7%
-
=308: Mean(s) 351.2, Within-instrument SD 21.6, %CV 6.1%
Method Comparison Study:
GEM® Hemochron™ 100 ACT+
- Study type: Method comparison study in accordance with CLSI EP09-A3.
- Sample size: Whole blood samples from 40 normal subjects, assayed at baseline and spiked with UFH to final concentrations of 1.0, 2.0, 3.0, 4.0, 5.0, and 6.0 units/mL.
- Key results:
- Comparison (n=280): GEM® Hemochron™ 100 vs Hemochron™ Signature Elite
- Passing-Bablok Regression: Intercept 2.877 (-1.572, 7.361), Slope 1.007 (0.988, 1.026), r 0.979
- % Bias at 400 s: 1.4%
- % Bias at 500 s: 1.2%
GEM® Hemochron™ 100 ACT-LR
- Study type: In-house method comparison study in accordance with CLSI EP09-A3.
- Sample size: Whole blood samples from 40 normal subjects, assayed at baseline and spiked with UFH to final concentrations of 0.5, 1.0, 1.5, and 2.5 units/mL.
- Key results:
- Comparison (n=215): GEM® Hemochron™ 100 vs Hemochron™ Signature Elite
- Passing-Bablok Regression: Intercept -6.00 (-15.39, 2.388), Slope 1.0000 (0.9612, 1.049), r 0.947
- % Bias at 225 s: -2.7%
- % Bias at 300 s: -2.0%
Conclusion: The performance of the GEM® Hemochron™ 100 is substantially equivalent to the cleared and currently marketed predicate device, Hemochron™ Signature Elite (K193041). The differences between the subject and predicate do not impact safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K193041, K941007, K960749, K120977
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
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.(b)
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.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
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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. This is a Traditional 510(k)
1. Sponsor/Application Information and Date [807.92(A)(1)]
| Owner/Manufacturer Name and Address: | Accriva Diagnostics, Inc.
6260 Sequence Drive
San Diego, CA 92121
FEI Number: 2250033
Establishment Registration Number: 3002721930 |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Name and Address: | Accriva Diagnostics, Inc.
6260 Sequence Drive
San Diego, CA 92121
FEI Number: 2250033
Establishment Registration Number: 3002721930 |
| Contact Person: | Brian James
Sr. Manager, Regulatory Affairs
Accriva Diagnostics, Inc.
(858) 263-2350
bjames@ilww.com |
| Application Correspondent: | Brian James
Sr. Manager, Regulatory Affairs
Accriva Diagnostics, Inc.
(858) 263-2350
bjames@ilww.com |
| Date Summary Prepared: | December 24th 2021 |
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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 | |
| 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 | |
| 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 | |
| 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) | |
| 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) | |
| 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 |
| analyzer that represents the next generation platform of the predicate Hemochron™ Signature | ||||
| Elite microcoagulation system. The analyzer employs the same fundamental opto-mechanical | ||||
| clot detection technology and the same analytical algorithms used by the predicate device for | ||||
| calculating test results. The single-use test cartridges for Activated Whole Blood Clotting | ||||
| Time Plus (ACT+) or Low Range ACT (ACT-LR) assays are identical to the cartridges used | ||||
| by the predicate analyzer. Whole Blood Controls used on the GEM® Hemochron™ 100 | ||||
| system are identical to those used on the Hemochron™ Signature Elite. The system is | ||||
| intended for use only in clinical settings requiring point of care testing. ACT results for | ||||
| patient blood samples or liquid control material are displayed as ACT Celite-equivalent | ||||
| values (CEV) in seconds. | ||||
| The analyzer contains a test chamber which warms a test cartridge to the required | ||||
| temperature, and it performs all operations to measure the clotting time of a whole blood | ||||
| sample after it is placed in the test cartridge and the test is started by the operator. The user | ||||
| interface includes a color touch screen that displays various action keys and an external | ||||
| barcode scanner for reading Operator identification number (OID), Patient identification | ||||
| (PID) number and lot numbers and expiry dates of liquid quality controls (QC). The operator | ||||
| uses the touch screen to select a command, set software configurations or enter information. | ||||
| The GEM® Hemochron™ 100 system is POCT1-A2 compliant and has Wi-Fi and Ethernet | ||||
| networking capability. It has increased storage for 10,000 patient and QC records. ACT+ and | ||||
| ACT-LR cartridge labels are modified to include a 2D barcode that identifies test type, lot | ||||
| number and expiry date, which is readable by the internal camera. Quality control features | ||||
| such as designation of QC levels, tagging of test results with date and time, and entry of OID | ||||
| and PID numbers are included and are similar to the predicate device. | ||||
| The GEM® Hemochron™ 100 system is intended for use at the point of care professional | ||||
| healthcare environments such as the Cardiovascular Operating Room and Catheterization lab | ||||
| and is designed to perform its essential tasks of performing in-vitro diagnostic blood | ||||
| coagulation-time tests without the use of a network connection. The device contains an | ||||
| 802.11 interface which supports WPA2 encryption as well as EAP authentication framework. | ||||
| The device is able to connect to a Wireless Local Area Network (WLAN) via 802.11 b/g/n | ||||
| connections at 2.4 and 5 GHz. The communications interfaces supported by the device are | ||||
| utilized to configure or update the device software by supervisory staff before deployment to | ||||
| 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- |
| 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, |
| 5250 MHz (a) – 16.00 dB, 5250 MHz (n) – 16.00 dB, 5600 MHz (a) - 17.50 dB, | |
| 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 |
| 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
Nominal
Power
dBm | Setpoint
Nominal
Power
dBm | Tolerance
dBm | Lower
Tolerance
dBm | Upper
Tolerance
dBm | |
|-----------------------------------|-------------------------------------------------------------------------------------------------|---------------------------------|-------------------------------------|------------------|---------------------------|---------------------------|------|
| WLAN -
2.4 GHz | 802.11b | N/A | 13.5 | $\pm2$ | 11.5 | 15.5 | |
| WLAN -
2.4 GHz | 802.11g | N/A | 17.0 | $\pm2$ | 15.0 | 19.0 | |
| WLAN -
2.4 GHz | 802.11n | N/A | 19.5 | $\pm2$ | 17.5 | 21.5 | |
| WLAN -
5 GHz
Band I,
IIA | 802.11a
(36-56) | N/A | 13.0 | $\pm2$ | 11.0 | 15.0 | |
| | WLAN –
5 GHz
Band IIA | 802.11a
(60-64) | N/A | 14.0 | $\pm$ 2 | 12.0 | 16.0 |
| | WLAN –
5 GHz
Band I,
IIA | 802.11n
(36-56) | N/A | 13.0 | $\pm$ 2 | 11.0 | 15.0 |
| | WLAN –
5 GHz
Band IIA | 802.11n
(60-64) | N/A | 14.0 | $\pm$ 2 | 12.0 | 16.0 |
| | WLAN –
5 GHz
Band IIC | 802.11a | N/A | 15.5 | $\pm$ 2 | 13.5 | 17.5 |
| | WLAN –
5 GHz
Band IIC | 802.11n | N/A | 15.5 | $\pm$ 2 | 13.5 | 17.5 |
| | WLAN –
5 GHz
Band III | 802.11a | N/A | 15.0 | $\pm$ 2 | 13.0 | 17.0 |
| | WLAN –
5 GHz
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
with a dried preparation of Celite and silicon dioxide activators, potato dextrin, stabilizers,
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™
Whole Blood
Quality
Controls, Level
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 | |
| 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 to the | |
| 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™ | |
| 100 system and any model of Hemochron™ Signature Series device. Instruments are | |
| portable, which allows testing at the point-of-care. For in vitro diagnostic use. For | |
| Professional Use, Rx Only. | |
| directCHECK™ Whole | |
| Blood Quality Controls, | |
| Level 1 and Level 2 | 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. |
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
Characteristics | Hemochron™ Signature Elite
(Predicate Device – K193041) | GEM® Hemochron™ 100 System
(Subject Device) |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Similarities | |
| 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. | ✓ Substantially Equivalent
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 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 |
| | | For in vitro diagnostic use. For Professional
Use, Rx Only. |
| Assays Used | Activated Clotting Time
(ACT+ and ACT-LR)
Activated Partial Thromboplastin Time (APTT
and APTT Citrate)
Prothrombin Time
(PT and citrate-PT) | ✓ Substantially Equivalent
Activated Clotting Time
(ACT+ and ACT-LR) only |
| Sample Type | Fresh Whole Blood | ✓ Substantially Equivalent
|
| Reagents | Citrated Whole Blood
Supplied in self-contained disposable cuvettes | Fresh Whole Blood only
✓ Substantially Equivalent
Supplied in self-contained disposable cartridges
(cuvettes) |
| Reported Results | Celite ACT Equivalent Time – ACT+ and
ACT-LR
PT, citrate-PT (INR)
Whole Blood Values – APTT, citrate-APTT,
PT, citrate-PT
Plasma Equivalent (PE) Values – APTT,
citrate-APTT, PT, citrate-PT | ✓ Substantially Equivalent
ACT Celite-equivalent value (CEV) in seconds
– ACT+ and ACT-LR |
| 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
Environment | 15° to 30°C | ✓ Substantially Equivalent
15° to 30°C |
| Clot
Detection
Method | Mechanical-optical clot detection | ✓ Substantially Equivalent |
| Liquid
QC
Requirement | Two levels - performed as directed | ✓ Substantially Equivalent |
| Electronic
QC
Requirement | Internal electronic QC | ✓ Substantially Equivalent
|
| Heater temperature
control | Thermistor – modulated by software | ✓ Substantially Equivalent
|
| Power | Battery or AC operated | ✓ Substantially Equivalent
|
| | Differences | |
| Operating System | IA188EBP | Android 7.1 (Nougat) |
| Software Version | 2.4 | 1.1 |
| Dimensions and
weight | Depth 9.4 cm (3.7 inches)
Width 19 cm (7.5 inches)
Height 5 cm (2.0 inches) | Width 10.2 cm (4.0 inches)
Length 19 cm (7.4 inches)
Depth 5 cm (2.0 inches) |
| | | |
| PC Connectivity | RS-232 and Ethernet ports; POCT1-A2 | Wi-Fi and Ethernet ports; POCT1-A2 |
| Data Storage
Capacity | 16- alphanumeric character OID / 20-
character PID; 600 QC and test records | 32- alphanumeric character OID / 32-character
PID; 10,000 QC and test records |
| Optical Detection
System | LED | Internal camera |
| User Interface | Keypad and barcode scanner | Touch screen and barcode scanner |
| OID / PID Input | Keypad | Touch screen and barcode scanner |
| LQC Parameter
Input | Keypad and barcode scanner | Touch screen and barcode scanner |
| Assay Parameter
Input | Keypad and barcode scanner | Touch screen and external barcode scanner |
| Supported Barcode
Formats | UPC/EAN, Code 128, Code 39, Trioptic Code
39, Code 93, Interleaved 2 of 5, Discrete 2 of
5, Codabar, and MSI Plessey | Aztec, Code 39, Code 128, Micro PDF417,
PDF417, QR |
| Incubation Warm
Up Time | Up to 200 seconds | 30 to 90 seconds |
6.1. GEM® Hemochron™ 100
12
13
6.2. GEM® Hemochron™ 100 ACT+
| Assay
Characteristics | Hemochron™ ACT+
(Predicate Device – K941007) | GEM® Hemochron™ 100 ACT+
(Subject Device) |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Similarities | |
| Intended Use | The Hemochron™ Jr. ACT+ is a quantitative
assay for monitoring
heparin anticoagulation during various medical
procedures. The ACT+ demonstrates linear
correlation to the anticoagulation effects of
heparin between 1.0 and 6.0 units/ml of blood.
It is intended for use in monitoring moderate to
high heparin doses frequently associated with
cardiac catheterization and cardiopulmonary
bypass surgery. The test is unaffected by
aprotinin. The ACT+ is not sensitive to very
low levels of heparin such as those encountered
in critical care. The Hemochron Jr. APTT and
ACT-LR are available for monitoring low
levels of heparin.
The ACT+ test is performed on any
Hemochron Jr. model using a fresh whole
blood sample. Each instrument is portable and
intended for bedside use. The instrument is not
intended for home use.
For in vitro Diagnostic Use, For Professional
Use, Rx Only. | ✓ Substantially Equivalent
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. |
14
| Reagents | Silica, Kaolin, Phospholipid, Stabilizers and Buffers | ✔ Substantially Equivalent
Silica, Kaolin, Phospholipid, Stabilizers and Buffers |
|------------------------|-------------------------------------------------------|-------------------------------------------------------------------------------------|
| Normal Range | 81-125 Celite Equivalent Seconds | ✔ Substantially Equivalent
82-133.8 Celite Equivalent Seconds |
| Heparin Linearity | 1.0-6.0 heparin units/mL of blood | ✔ Substantially Equivalent
1.0-6.0 heparin units/mL of blood |
| Sample Type | Fresh Whole Blood | ✔ Substantially Equivalent
Fresh Whole Blood |
| Controls | directCHECK™ Whole Blood Controls | ✔ Substantially Equivalent
directCHECK™ Whole Blood Controls |
| Packaging | 45 pouched single-use test cuvettes | ✔ Substantially Equivalent
45 pouched single-use test cartridges (cuvettes) |
| Storage
Temperature | 2-8°C | ✔ Substantially Equivalent
2-8°C |
| Differences | | |
| Label | Hole Code read by instrument | 2D Barcode read by instrument |
| Catalog Number | JACT+ | 000GACT+ |
NOTE: 000GACT+ is identical to JACT+, in every aspect except for the noted distinctions (e.g. name and 2D barcode).
6.3. GEM® Hemochron™ 100 ACT-LR
| Assay
Characteristics | Hemochron™ ACT-LR
(Predicate Device – K960749) | GEM® Hemochron™ 100 ACT-LR
(Subject Device) |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Hemochron™ Jr. ACT-LR is a
quantitative assay for monitoring heparin
anticoagulation during various medical
procedures. The ACT-LR demonstrates linear
correlation to the anticoagulation effects of
heparin up to 2.5 units/ml of blood. It is
intended for use in monitoring low to moderate
heparin doses frequently associated with
procedures such as cardiac cath-eterization,
Extracorporeal Membrane Oxygenation
(ECMO), hemodialysis, and Percutaneous
Transluminal Coronary Angioplasty. (The
Hemochron Jr. ACT+ [JACT+] test is available
for monitoring moderate to high levels [1-6
units/ml] of heparin.)
The ACT-LR test is performed on any
Hemochron Jr. model using a fresh whole
blood sample. Each instrument is portable and
is intended for bedside use. The instrument is
not intended for home use. | ✔ Substantially Equivalent
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.
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. |
| | Similarities | |
15
| | For in vitro Diagnostic Use, For Professional
Use, Rx Only. | For in vitro diagnostic use. For Professional
Use, Rx Only. |
|------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Reagents | Celite and Silicon Dioxide Activators, Potato
Dextrin, Stabilizers and Buffers | ✓ Substantially Equivalent
Celite and Silicon Dioxide Activators, Potato
Dextrin, Stabilizers and Buffers |
| Normal Range | 113-149 Celite Equivalent Seconds | ✓ Substantially Equivalent
116-155 Celite Equivalent Seconds |
| Heparin Linearity | Up to 2.5 heparin units/mL of blood | ✓ Substantially Equivalent
Up to 2.5 heparin units/mL of blood |
| Sample Type | Fresh Whole Blood | ✓ Substantially Equivalent
Fresh Whole Blood |
| Controls | directCHECK™ Whole Blood Quality
Controls | ✓ Substantially Equivalent
directCHECK™ Whole Blood Quality Controls |
| Packaging | 45 pouches, each containing 1 sing-use test
cuvette | ✓ Substantially Equivalent
45 pouches, each containing 1 sing-use test
cartridge (cuvette) |
| Storage
Temperature | 2-8°C | ✓ Substantially Equivalent
2-8°C |
| Differences | | |
| Label | Hole Code read by instrument | 2D Barcode read by instrument |
| Catalog Number | JACT-LR | 000GACT-LR |
NOTE: 000GACT-LR is identical to JACT-LR, in every aspect except for the noted distinctions (e.g. name and 2D barcode).
6.4. directCHECK™ Whole Blood Quality Controls
| Control
Characteristics | directCHECK™ Whole Blood Controls
ACT+ and ACT-LR
(Predicate Device – K120977) | directCHECK™ Whole Blood Quality
Controls
(Subject Device) |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | 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 Microcoagulation test cuvettes.
For in vitro Diagnostic Use. For Professional
Use, Rx Only. | ✔ Substantially Equivalent
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. |
| Preparation | Distilled Water, Sodium Chloride, Tween® 20,
ProClin® and anticoagulant | ✔ Substantially Equivalent
Distilled Water, Sodium Chloride, Tween® 20,
ProClin® and anticoagulant |
| Packaging | 15 single use vials | ✔ Substantially Equivalent
15 single use vials |
| Storage
Temperature | 2-8°C | ✔ Substantially Equivalent
2-8°C |
16
| Differences | ||
|---|---|---|
| Catalog Number | DCJACT-N | 000DCGACT-1 |
| DCJACT-A | 000DCGACT-2 | |
| DCJLR-N | 000DCGLR-1 | |
| DCJLR-A | 000DCGLR-2 |
NOTE: 000DCGACT-1, 000DCGACT-2, 000DCGLR-1, 000DCGLR-2 are identical to DCJACT-A, DCJLR-N, DCJLR-A in every aspect except for the noted distinctions (e.g. name).
7. Summary of Non-Clinical Performance Data 7.1. GEM Hemochron 100 System
The GEM Hemochron 100 System was successfully tested for electrical safety, emissions and immunity, and wireless performance to the following standards:
| Description | Standard | Title |
|---|---|---|
| Electrical Safety | IEC 61010-1 | Safety requirements for electrical equipment for measurement, control and |
| laboratory use. Part 1: General requirements | ||
| IEC 61010-2-010 | Safety requirements for electrical equipment for measurement, control and | |
| laboratory use - Part 2-010: Particular requirements for laboratory equipment | ||
| for the heating of materials | ||
| IEC 61010-2-101 | Safety requirements for electrical equipment for measurement, control and | |
| laboratory use - Part 2-101. Particular requirements for in vitro diagnostic | ||
| (IVD) medical equipment | ||
| Emissions | IEC 61326-1 | Electrical equipment for measurement, control and laboratory use - EMC |
| requirements - Part 1: General Requirements | ||
| CISPR 11 | Industrial, scientific and medical equipment - Radio- frequency disturbance | |
| characteristics - Limits and methods of measurement | ||
| IEC 61000-3-2 | Electromagnetic compatibility (EMC) – Part 3-2: Limits - Limits for | |
| harmonic current emissions | ||
| IEC 61000-3-3 | Electromagnetic compatibility (EMC) - Part 3-3: Limits - Limitation of | |
| voltage changes, voltage fluctuations and flicker in public low - voltage | ||
| supply systems, for equipment with rated current ≤16 A per phase and not | ||
| subject to conditional connection. | ||
| FCC Part 15B | ||
| §15.109 | Radiated emission limits | |
| FCC Part 15B | ||
| §15.107 | Conducted Limits | |
| Immunity | IEC 60601-1-2 | Medical electrical equipment - Part 1-2: General requirements for basic |
| safety and essential performance – Collateral standard: Eletromagnetic | ||
| Disturbances - Requirements and tests | ||
| IEC 61000-4-2 | Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement | |
| techniques - Electrostatic discharge immunity test | ||
| IEC 61000-4-3 | Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement | |
| techniques - Radiated, radio-frequency, electromagnetic field immunity test | ||
| IEC 61000-4-4 | Electromagnetic compatibility (EMC) - Part 4-4: Testing and measurement | |
| techniques - Electrical fast transient/burst immunity test | ||
| IEC 61000-4-5 | Electromagnetic compatibility (EMC) - Part 4-5: Testing and measurement | |
| techniques - Surge immunity test | ||
| IEC 61000-4-6 | Electromagnetic compatibility (EMC) – Part 4-6: Testing and measurement | |
| techniques - Immunity to conducted disturbances, induced by radio- | ||
| frequency fields | ||
| IEC 61000-4-8 | Electromagnetic compatibility (EMC) - Part 4-8: Testing and measurement | |
| techniques - Power frequency magnetic field immunity test | ||
| IEC 61000-4-11 | Electromagnetic compatibility (EMC) - Part 4-11: Testing and measurement | |
| techniques - Voltage dips, short interruptions and voltage variations | ||
| immunity tests | ||
| AIM 7351731 | Medical Electrical Equipment and System Electromagnetic Immunity Test | |
| for Exposure to Radio Frequency Identification Readers | ||
| ISO 14223 | Radiofrequency identification of animals - Advanced transponders | |
| ISO/IEC 14443-3 | Identification cards - Contactless integrated circuit cards - Proximity | |
| cards - Part 3: Initialization and anticollision | ||
| ISO/IEC 14443-4 | Cards and security devices for personal identification - Contactless | |
| proximity objects - Part 4: Transmission protocol | ||
| ISO/IEC 15693-3 | Identification cards - Contactless integrated circuit cards - Vicinity cards |
- Part 3: Anticollision and transmission protocol | |
| ISO/IEC 18000-3 | Information technology - Radio frequency identification for item
management - Part 3: Parameters for air interface communications at 13,56
MHz | |
| ISO/IEC 18000-7 | Information technology - Radio frequency identification for item
management - Part 7: Parameters for active air interface communications at
433 MHz | |
| ISO/IEC 18000-
63 | Information technology - Radio frequency identification for item
management - Part 63: Parameters for air interface communications at 860 MHz | |
| Wireless | FCC Part 15C
§15.247 | Operation within the bands 902-928 MHz, 2400-2483.5 MHz, and 5725-
5850 MHz |
| | ISO/IEC 18000-4 | Information technology — Radio frequency identification for item
management — Part 4: Parameters for air interface communications at 2,45
GHz |
| | FCC Part 15B
§15.407 | General technical requirements |
17
18
7.2. Precision - Liquid Quality Controls (Celite Equivalent Seconds):
LQC samples were tested in accordance with CLSI EP05-A3 with a test design of 1 site, 20 days (non-sequential), 2 runs per day, and 2 replicates per run, across 2 GEM® Hemochron™ 100 ACT+ and ACT-LR cartridge lots using the GEM® Hemochron™ 100 System
7.2.1. GEM® Hemochron™ 100 ACT+
| Within-run | ||||
|---|---|---|---|---|
| N | Mean(s) | SD | %CV | |
| Level 1 | 640 | 157.7 | 11.4 | 7.2% |
| Level 2 | 640 | 419.0 | 9.7 | 2.3% |
7.2.2.GEM® Hemochron™ 100 ACT-LR
| Within-run | ||||
|---|---|---|---|---|
| N | Mean(s) | SD | %CV | |
| Level 1 | 640 | 117.1 | 10.5 | 9.0% |
| Level 2 | 640 | 272.3 | 19.1 | 7.0% |
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7.3. Precision - Donor whole blood samples (Celite Equivalent Seconds)
The study design included a total of 20 test replicates per donor sample (e.g. 2 operators x 5 instruments per operator x 2 test results per instrument).
| Sample Target Ranges | N | Mean(s) | Within-instrument | |
|---|---|---|---|---|
| SD | %CV | |||
| 68-180 | 20 | 105.9 | 5.6 | 5.3% |
| 181-360 | 20 | 235.6 | 22.3 | 9.5% |
| 361-540 | 20 | 375.7 | 6.6 | 1.8% |
| 541-720 | 20 | 708.3 | 41.3 | 5.8% |
| >=721 | 19 | 760.1 | 69.3 | 9.1% |
7.3.1.GEM® Hemochron™ 100 ACT+
7.3.2.GEM® Hemochron™ 100 ACT-LR
| Within-instrument | ||||
|---|---|---|---|---|
| Sample Target Ranges | N | Mean(s) | SD | %CV |
| 65-145 | 20 | 117.5 | 5.9 | 5.0% |
| 146-226 | 20 | 209.8 | 10.9 | 5.2% |
| 227-307 | 20 | 266.8 | 12.5 | 4.7% |
| >=308 | 20 | 351.2 | 21.6 | 6.1% |
7.4. Method Comparison Study 7.4.1.GEM® Hemochron™ 100 ACT+
A method comparison study was performed in accordance with CLSI EP09-A3, using whole blood samples from 40 normal subjects, comparing the GEM® Hemochron™ 100 and Hemochron™ Signature Elite. Samples were assayed at baseline and spiked with UFH to final concentrations of 1.0, 2.0, 3.0, 4.0, 5.0, and 6.0 units/mL. The results were compared and the bias was determined at medical decision levels of 400s and 500s.
| Comparison | n | Results of Passing-Bablok Regression | % Bias at | |||
|---|---|---|---|---|---|---|
| Intercept (95% C.I.) | Slope (95% C.I.) | r | 400 s | 500 s | ||
| GEM® HemochronTM 100 | ||||||
| vs HemochronTM Signature | ||||||
| Elite | 280 | 2.877 (-1.572, 7.361) | 1.007 (0.988, 1.026) | 0.979 | 1.4% | 1.2% |
20
7.4.2. GEM® Hemochron™ 100 ACT-LR
An in-house method comparison study was performed in accordance with CLSI EP09-A3 using whole blood samples from 40 normal subjects, comparing GEM® Hemochron™ 100 and Hemochron™ Signature Elite. Samples were assayed at baseline and spiked with UFH to final concentrations of 0.5, 1.0, 1.5, and 2.5 units/mL. The results were compared and the bias was determined at medical decision levels of 225s and 300s.
| Comparison | Results of Passing-Bablok Regression | % Bias at | ||||
|---|---|---|---|---|---|---|
| n | Intercept (95% C.I.) | Slope (95% C.I.) | r | 225 s | 300 s | |
| GEM® Hemochron™ 100 | ||||||
| vs Hemochron™ Signature | ||||||
| Elite | 215 | -6.00 (-15.39, 2.388) | 1.0000 (0.9612, | |||
| 1.049) | 0.947 | -2.7% | -2.0% |
8. Conclusion:
Based on the substantial equivalence comparison and the results of the conducted performance evaluations, it was concluded that the performance of the GEM® Hemochron™ 100 to be substantially equivalent to the cleared and currently marketed predicate device, Hemochron™ Signature Elite (K193041). The differences between the subject and predicate do not impact safety and effectiveness.