(518 days)
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.
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.
The provided text details the 510(k) summary for the Accriva Diagnostics, Inc. GEM Hemochron 100 System and associated tests and controls. This document aims to demonstrate the substantial equivalence of the new device to existing legally marketed predicate devices. The study described focuses on the comparison between the new GEM Hemochron 100 system and the predicate Hemochron Signature Elite, rather than proving the device meets acceptance criteria in a traditional sense of a clinical trial with predefined success/failure thresholds against a ground truth.
Instead, the provided text describes performance data collected to demonstrate substantial equivalence to an already cleared predicate device. This is a common pathway for FDA 510(k) clearance, where a new device is compared to a legally marketed predicate to show it is as safe and effective.
Here's an attempt to answer your questions based on the provided text, reinterpreting "acceptance criteria" as the performance metrics and comparability demonstrated for substantial equivalence:
1. A table of acceptance criteria and the reported device performance
For a 510(k) submission, "acceptance criteria" for performance studies are typically framed as demonstrating equivalence or non-inferiority to the predicate device within acceptable statistical bounds. The reported performance is then compared to that of the predicate. The document doesn't explicitly state quantitative acceptance criteria in a "pass/fail" table format, but rather presents the results of equivalence studies.
Here's a summary of the performance data presented, emphasizing the comparison to the predicate:
| Performance Metric | Acceptance Criteria (Demonstration of Equivalence to Predicate) | Reported Device Performance (GEM Hemochron 100) |
|---|---|---|
| Precision (LQC) - ACT+ | Within-run CV comparable to established performance for similar devices. | Level 1: Mean 157.7s, SD 11.4s, CV 7.2%Level 2: Mean 419.0s, SD 9.7s, CV 2.3% |
| Precision (LQC) - ACT-LR | Within-run CV comparable to established performance for similar devices. | Level 1: Mean 117.1s, SD 10.5s, CV 9.0%Level 2: Mean 272.3s, SD 19.1s, CV 7.0% |
| Precision (Whole Blood) - ACT+ | Within-instrument CV comparable to established performance for similar devices across target ranges. | Target 68-180s: Mean 105.9s, SD 5.6s, CV 5.3%Target 181-360s: Mean 235.6s, SD 22.3s, CV 9.5%Target 361-540s: Mean 375.7s, SD 6.6s, CV 1.8%Target 541-720s: Mean 708.3s, SD 41.3s, CV 5.8%Target >=721s: Mean 760.1s, SD 69.3s, CV 9.1% |
| Precision (Whole Blood) - ACT-LR | Within-instrument CV comparable to established performance for similar devices across target ranges. | Target 65-145s: Mean 117.5s, SD 5.9s, CV 5.0%Target 146-226s: Mean 209.8s, SD 10.9s, CV 5.2%Target 227-307s: Mean 266.8s, SD 12.5s, CV 4.7%Target >=308s: Mean 351.2s, SD 21.6s, CV 6.1% |
| Method Comparison (ACT+) | Linear correlation and low bias (e.g., <5%) compared to predicate at medical decision levels. | Intercept: 2.877 (-1.572, 7.361)Slope: 1.007 (0.988, 1.026)r: 0.979% Bias at 400s: 1.4%% Bias at 500s: 1.2% |
| Method Comparison (ACT-LR) | Linear correlation and low bias (e.g., <5%) compared to predicate at medical decision levels. | Intercept: -6.00 (-15.39, 2.388)Slope: 1.0000 (0.9612, 1.049)r: 0.947% Bias at 225s: -2.7%% Bias at 300s: -2.0% |
| Electrical Safety, Emissions, Immunity, Wireless Performance | Compliance with relevant international standards (IEC, ISO, FCC etc.). | Successfully tested to IEC 61010-1, IEC 61010-2-010, IEC 61010-2-101, IEC 61326-1, CISPR 11, IEC 61000 series (various parts), AIM 7351731, ISO 14223, ISO/IEC 14443-3/4, ISO/IEC 15693-3, ISO/IEC 18000 series (various parts), FCC Part 15B/C. |
2. Sample size(s) used for the test set and the data provenance
- Precision (Liquid Quality Controls):
- Sample Size: N=640 for each level (Level 1 and Level 2) for both ACT+ and ACT-LR.
- Provenance: This data is generated internally as part of method validation. It is not specified, but typically this would be prospective data collected for the submission. The location is not specified, but likely within the manufacturer's R&D facilities.
- Precision (Donor Whole Blood Samples):
- Sample Size: N=20 for each sample target range (ACT+ and ACT-LR). Note: One sample for ACT+ had N=19.
- Provenance: "Donor whole blood samples" suggests human biological samples. This would be prospective data collected for the submission. The country of origin is not specified.
- Method Comparison Study:
- Sample Size: 280 samples for ACT+ (derived from 40 normal subjects at baseline and 6 spiked UFH concentrations). 215 samples for ACT-LR (derived from 40 normal subjects at baseline and 4 spiked UFH concentrations).
- Provenance: "Whole blood samples from 40 normal subjects." This is prospective clinical data. The study was "in accordance with CLSI EP09-A3," a standard for method comparison, and was an "in-house method comparison study." The country of origin is not specified but is typically internal to the applicant's operations or affiliated clinical sites.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of submission (for a coagulation system) does not typically involve expert readers or adjudication for "ground truth" in the way an imaging AI device might. The "ground truth" is typically the reference method or the predicate device's measurement which the new device is being compared against. In this case:
- For precision, the performance of the device itself (repeatability and reproducibility) is the focus, not comparison to external expert-defined ground truth.
- For method comparison, the "ground truth" or reference is the measurements generated by the predicate device (Hemochron Signature Elite) on the same samples. There are no human experts involved in establishing this type of ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for this type of in vitro diagnostic device study. Adjudication methods like 2+1 or 3+1 are used in medical imaging studies where human experts provide subjective interpretations that need to be reconciled to form a consensus ground truth. Here, the measurements are quantitative.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is an in vitro diagnostic device for measuring blood coagulation, not an AI imaging device involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a standalone instrument that performs the coagulation tests. Its performance is measured directly (e.g., precision, method comparison to a predicate instrument). There isn't a separate "algorithm only" component that would perform independently of the physical instrument and its cartridges. The studies described (precision and method comparison) are essentially standalone performance evaluations of the device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For precision studies, the "ground truth" is the true value of the quality control material or the mean of repeated measurements for patient samples. This is established by the properties of the controls or the statistical analysis of the measurements.
- For method comparison studies, the "ground truth" is the result obtained from the predicate device (Hemochron™ Signature Elite). The new device's measurements are compared to those of the predicate to demonstrate substantial equivalence.
8. The sample size for the training set
The concept of a "training set" is typically associated with machine learning or artificial intelligence models. This document describes a traditional medical device (an in vitro diagnostic coagulation system) that uses established opto-mechanical clot detection technology and analytical algorithms, which are stated to be "identical to the cartridges used by the predicate analyzer." Therefore, there is no explicit mention or implication of a distinct "training set" for a machine learning model, as the device's operational principles are based on known physical and chemical reactions, not adaptive algorithms trained on large datasets.
9. How the ground truth for the training set was established
As there is no mention of a "training set" in the context of machine learning, this question is not applicable. The device's underlying principles are based on established scientific methods for coagulation testing, which inherently define the measurement parameters.
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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.
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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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 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.
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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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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 DriveSan Diego, CA 92121FEI Number: 2250033Establishment Registration Number: 3002721930 |
|---|---|
| Submitter Name and Address: | Accriva Diagnostics, Inc.6260 Sequence DriveSan Diego, CA 92121FEI Number: 2250033Establishment Registration Number: 3002721930 |
| Contact Person: | Brian JamesSr. Manager, Regulatory AffairsAccriva Diagnostics, Inc.(858) 263-2350bjames@ilww.com |
| Application Correspondent: | Brian JamesSr. Manager, Regulatory AffairsAccriva Diagnostics, Inc.(858) 263-2350bjames@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 II21 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 II21 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 II21 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 coagulationanalyzer that represents the next generation platform of the predicate Hemochron™ SignatureElite microcoagulation system. The analyzer employs the same fundamental opto-mechanicalclot detection technology and the same analytical algorithms used by the predicate device forcalculating test results. The single-use test cartridges for Activated Whole Blood ClottingTime Plus (ACT+) or Low Range ACT (ACT-LR) assays are identical to the cartridges usedby the predicate analyzer. Whole Blood Controls used on the GEM® Hemochron™ 100system are identical to those used on the Hemochron™ Signature Elite. The system isintended for use only in clinical settings requiring point of care testing. ACT results forpatient blood samples or liquid control material are displayed as ACT Celite-equivalentvalues (CEV) in seconds.The analyzer contains a test chamber which warms a test cartridge to the requiredtemperature, and it performs all operations to measure the clotting time of a whole bloodsample after it is placed in the test cartridge and the test is started by the operator. The userinterface includes a color touch screen that displays various action keys and an externalbarcode scanner for reading Operator identification number (OID), Patient identification(PID) number and lot numbers and expiry dates of liquid quality controls (QC). The operatoruses 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 Ethernetnetworking capability. It has increased storage for 10,000 patient and QC records. ACT+ andACT-LR cartridge labels are modified to include a 2D barcode that identifies test type, lotnumber and expiry date, which is readable by the internal camera. Quality control featuressuch as designation of QC levels, tagging of test results with date and time, and entry of OIDand 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 professionalhealthcare environments such as the Cardiovascular Operating Room and Catheterization laband is designed to perform its essential tasks of performing in-vitro diagnostic bloodcoagulation-time tests without the use of a network connection. The device contains an802.11 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/nconnections at 2.4 and 5 GHz. The communications interfaces supported by the device areutilized to configure or update the device software by supervisory staff before deployment tothe 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 |
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4. Device Description [807.92 (A)(4)]
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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 616217D04 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 | 3GPPNominalPowerdBm | SetpointNominalPowerdBm | TolerancedBm | LowerTolerancedBm | UpperTolerancedBm | |
|---|---|---|---|---|---|---|---|
| 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 GHzBand I,IIA | 802.11a(36-56) | N/A | 13.0 | $\pm2$ | 11.0 | 15.0 | |
| WLAN –5 GHzBand IIA | 802.11a(60-64) | N/A | 14.0 | $\pm$ 2 | 12.0 | 16.0 | |
| WLAN –5 GHzBand I,IIA | 802.11n(36-56) | N/A | 13.0 | $\pm$ 2 | 11.0 | 15.0 | |
| WLAN –5 GHzBand IIA | 802.11n(60-64) | N/A | 14.0 | $\pm$ 2 | 12.0 | 16.0 | |
| WLAN –5 GHzBand IIC | 802.11a | N/A | 15.5 | $\pm$ 2 | 13.5 | 17.5 | |
| WLAN –5 GHzBand IIC | 802.11n | N/A | 15.5 | $\pm$ 2 | 13.5 | 17.5 | |
| WLAN –5 GHzBand III | 802.11a | N/A | 15.0 | $\pm$ 2 | 13.0 | 17.0 | |
| WLAN –5 GHzBand 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 |
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| Test (ACT-LR) | number and expiry date. The cartridge is a self-contained disposable test chamber preloadedwith 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 BloodQualityControls, Level1 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 aquantitative assay for monitoring anticoagulation with low to moderate unfractionatedheparin (UFH) doses in fresh whole blood samples. This test is intended for monitoringUFH administered during extracorporeal life support and cardiology procedures. TheGEM® Hemochron™ 100 ACT-LR test demonstrates linear correlation to theanticoagulation effects of UFH concentrations up to 2.5 units/mL.For in vitro diagnostic use. For Professional Use, Rx Only. | |
| GEM® Hemochron™100 Activated ClottingTime Plus Test (ACT+) | The GEM® Hemochron™ 100 ACT+ (Activated Clotting Time Plus) test is aquantitative assay for monitoring anticoagulation with moderate to high unfractionatedheparin (UFH) doses in fresh whole blood samples. This test is intended for monitoringUFH administered during cardiovascular surgery and cardiac ablation procedures. TheGEM® Hemochron™ 100 ACT+ demonstrates linear correlation to the anticoagulationeffects 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 isportable, which allows testing at the point-of-care. For in vitro diagnostic use. ForProfessional Use, Rx Only. | |
| GEM® Hemochron™100 Low Range ActivatedClotting Time Test (ACT-LR) | The GEM® Hemochron™ 100 ACT-LR (Low Range Activated Clotting Time) test is aquantitative assay for monitoring anticoagulation with low to moderate unfractionatedheparin (UFH) doses in fresh whole blood samples. This test is intended for monitoringUFH administered during extracorporeal life support and cardiology procedures. TheGEM® Hemochron™ 100 ACT-LR test demonstrates linear correlation to theanticoagulation 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 areportable, which allows testing at the point-of-care. For in vitro diagnostic use. ForProfessional Use, Rx Only. | |
| directCHECK™ WholeBlood Quality Controls,Level 1 and Level 2 | The directCHECK™ Whole Blood Quality Controls are dried whole blood preparationswhich have been assayed and are intended to be used to perform quality control assaysusing the Hemochron™ test cartridges. For in vitro Diagnostic Use. For Professional Use,Rx Only. |
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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.
| InstrumentCharacteristics | Hemochron™ Signature Elite(Predicate Device – K193041) | GEM® Hemochron™ 100 System(Subject Device) |
|---|---|---|
| Similarities | ||
| Intended Use | The Hemochron™ Signature Elite WholeBlood Microcoagulation System is a battery-operated, hand-held instrument that performsindividual point-of-care coagulation tests onfresh or citrated whole blood. These testsinclude: Activated Clotting Time (ACT+ andACT-LR), Activated Partial ThromboplastinTime (APTT and APTT Citrate), andProthrombin Time (PT and PT Citrate). Thesystem is intended to be used with test cuvettesthat are available from the manufacturer.For in vitro Diagnostic Use. For professionaluse. Rx only. | ✓ Substantially EquivalentThe GEM® Hemochron™ 100 System is abattery-operated portable instrument thatperforms individual in vitro quantitativecoagulation tests on fresh whole blood. Thesystem is intended to be used with test cartridgesavailable from the manufacturer and includetests for Activated Clotting Time (ACT+) andLow Range Activated Clotting Time (ACT-LR).The system is intended for use only in point-of-care settings for patients aged 18 years andabove.The GEM® Hemochron™ 100 ACT+(Activated Clotting Time Plus) test is aquantitative assay for monitoringanticoagulation with moderate to highunfractionated heparin (UFH) doses in freshwhole blood samples. This test is intended formonitoring UFH administered duringcardiovascular surgery and cardiac ablationprocedures. The GEM® Hemochron™ 100ACT+ demonstrates linear correlation to theanticoagulation effects of UFH concentrationsof 1.0 to 6.0 units/mL.The GEM® Hemochron™ 100 ACT-LR (LowRange Activated Clotting Time) test is aquantitative assay for monitoringanticoagulation with low to moderateunfractionated heparin (UFH) doses in freshwhole blood samples. This test is intended formonitoring UFH administered duringextracorporeal life support and cardiologyprocedures. The GEM® Hemochron™ 100ACT-LR test demonstrates linear correlation tothe anticoagulation effects of UFH |
| For in vitro diagnostic use. For ProfessionalUse, Rx Only. | ||
| Assays Used | Activated Clotting Time(ACT+ and ACT-LR)Activated Partial Thromboplastin Time (APTTand APTT Citrate)Prothrombin Time(PT and citrate-PT) | ✓ Substantially EquivalentActivated Clotting Time(ACT+ and ACT-LR) only |
| Sample Type | Fresh Whole Blood | ✓ Substantially Equivalent |
| Reagents | Citrated Whole BloodSupplied in self-contained disposable cuvettes | Fresh Whole Blood only✓ Substantially EquivalentSupplied in self-contained disposable cartridges(cuvettes) |
| Reported Results | Celite ACT Equivalent Time – ACT+ andACT-LRPT, citrate-PT (INR)Whole Blood Values – APTT, citrate-APTT,PT, citrate-PTPlasma Equivalent (PE) Values – APTT,citrate-APTT, PT, citrate-PT | ✓ Substantially EquivalentACT 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 |
| OperatingEnvironment | 15° to 30°C | ✓ Substantially Equivalent15° to 30°C |
| ClotDetectionMethod | Mechanical-optical clot detection | ✓ Substantially Equivalent |
| LiquidQCRequirement | Two levels - performed as directed | ✓ Substantially Equivalent |
| ElectronicQCRequirement | Internal electronic QC | ✓ Substantially Equivalent |
| Heater temperaturecontrol | 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 andweight | 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 StorageCapacity | 16- alphanumeric character OID / 20-character PID; 600 QC and test records | 32- alphanumeric character OID / 32-characterPID; 10,000 QC and test records |
| Optical DetectionSystem | LED | Internal camera |
| User Interface | Keypad and barcode scanner | Touch screen and barcode scanner |
| OID / PID Input | Keypad | Touch screen and barcode scanner |
| LQC ParameterInput | Keypad and barcode scanner | Touch screen and barcode scanner |
| Assay ParameterInput | Keypad and barcode scanner | Touch screen and external barcode scanner |
| Supported BarcodeFormats | UPC/EAN, Code 128, Code 39, Trioptic Code39, Code 93, Interleaved 2 of 5, Discrete 2 of5, Codabar, and MSI Plessey | Aztec, Code 39, Code 128, Micro PDF417,PDF417, QR |
| Incubation WarmUp Time | Up to 200 seconds | 30 to 90 seconds |
6.1. GEM® Hemochron™ 100
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6.2. GEM® Hemochron™ 100 ACT+
| AssayCharacteristics | Hemochron™ ACT+(Predicate Device – K941007) | GEM® Hemochron™ 100 ACT+(Subject Device) |
|---|---|---|
| Similarities | ||
| Intended Use | The Hemochron™ Jr. ACT+ is a quantitativeassay for monitoringheparin anticoagulation during various medicalprocedures. The ACT+ demonstrates linearcorrelation to the anticoagulation effects ofheparin between 1.0 and 6.0 units/ml of blood.It is intended for use in monitoring moderate tohigh heparin doses frequently associated withcardiac catheterization and cardiopulmonarybypass surgery. The test is unaffected byaprotinin. The ACT+ is not sensitive to verylow levels of heparin such as those encounteredin critical care. The Hemochron Jr. APTT andACT-LR are available for monitoring lowlevels of heparin.The ACT+ test is performed on anyHemochron Jr. model using a fresh wholeblood sample. Each instrument is portable andintended for bedside use. The instrument is notintended for home use.For in vitro Diagnostic Use, For ProfessionalUse, Rx Only. | ✓ Substantially EquivalentThe GEM® Hemochron™ 100 ACT+(Activated Clotting Time Plus) test is aquantitative assay for monitoringanticoagulation with moderate to highunfractionated heparin (UFH) doses in freshwhole blood samples. This test is intended formonitoring UFH administered duringcardiovascular surgery and cardiac ablationprocedures. The GEM® Hemochron™ 100ACT+ demonstrates linear correlation to theanticoagulation effects of UFH concentrationsof 1.0 to 6.0 units/mL.The GEM® Hemochron™ 100 ACT+ test canbe performed on the GEM® Hemochron™ 100System and any model of Hemochron™Signature Series device. Each instrument isportable, which allows testing at the point-of-care.For in vitro diagnostic use. For ProfessionalUse, Rx Only. |
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| Reagents | Silica, Kaolin, Phospholipid, Stabilizers and Buffers | ✔ Substantially EquivalentSilica, Kaolin, Phospholipid, Stabilizers and Buffers |
|---|---|---|
| Normal Range | 81-125 Celite Equivalent Seconds | ✔ Substantially Equivalent82-133.8 Celite Equivalent Seconds |
| Heparin Linearity | 1.0-6.0 heparin units/mL of blood | ✔ Substantially Equivalent1.0-6.0 heparin units/mL of blood |
| Sample Type | Fresh Whole Blood | ✔ Substantially EquivalentFresh Whole Blood |
| Controls | directCHECK™ Whole Blood Controls | ✔ Substantially EquivalentdirectCHECK™ Whole Blood Controls |
| Packaging | 45 pouched single-use test cuvettes | ✔ Substantially Equivalent45 pouched single-use test cartridges (cuvettes) |
| StorageTemperature | 2-8°C | ✔ Substantially Equivalent2-8°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
| AssayCharacteristics | Hemochron™ ACT-LR(Predicate Device – K960749) | GEM® Hemochron™ 100 ACT-LR(Subject Device) |
|---|---|---|
| Intended Use | The Hemochron™ Jr. ACT-LR is aquantitative assay for monitoring heparinanticoagulation during various medicalprocedures. The ACT-LR demonstrates linearcorrelation to the anticoagulation effects ofheparin up to 2.5 units/ml of blood. It isintended for use in monitoring low to moderateheparin doses frequently associated withprocedures such as cardiac cath-eterization,Extracorporeal Membrane Oxygenation(ECMO), hemodialysis, and PercutaneousTransluminal Coronary Angioplasty. (TheHemochron Jr. ACT+ [JACT+] test is availablefor monitoring moderate to high levels [1-6units/ml] of heparin.)The ACT-LR test is performed on anyHemochron Jr. model using a fresh wholeblood sample. Each instrument is portable andis intended for bedside use. The instrument isnot intended for home use. | ✔ Substantially EquivalentThe GEM® Hemochron™ 100 ACT-LR (LowRange Activated Clotting Time) test is aquantitative assay for monitoringanticoagulation with low to moderateunfractionated heparin (UFH) doses in freshwhole blood samples. This test is intended formonitoring UFH administered duringextracorporeal life support and cardiologyprocedures. The GEM® Hemochron™ 100ACT-LR test demonstrates linear correlation tothe anticoagulation effects of UFHconcentrations up to 2.5 units/mL.The GEM® Hemochron™ 100 ACT-LR testcan be performed on the GEM® Hemochron™100 system and any model of Hemochron™Signature Series device. Instruments areportable, which allows testing at the point-of-care. |
| Similarities |
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| For in vitro Diagnostic Use, For ProfessionalUse, Rx Only. | For in vitro diagnostic use. For ProfessionalUse, Rx Only. | |
|---|---|---|
| Reagents | Celite and Silicon Dioxide Activators, PotatoDextrin, Stabilizers and Buffers | ✓ Substantially EquivalentCelite and Silicon Dioxide Activators, PotatoDextrin, Stabilizers and Buffers |
| Normal Range | 113-149 Celite Equivalent Seconds | ✓ Substantially Equivalent116-155 Celite Equivalent Seconds |
| Heparin Linearity | Up to 2.5 heparin units/mL of blood | ✓ Substantially EquivalentUp to 2.5 heparin units/mL of blood |
| Sample Type | Fresh Whole Blood | ✓ Substantially EquivalentFresh Whole Blood |
| Controls | directCHECK™ Whole Blood QualityControls | ✓ Substantially EquivalentdirectCHECK™ Whole Blood Quality Controls |
| Packaging | 45 pouches, each containing 1 sing-use testcuvette | ✓ Substantially Equivalent45 pouches, each containing 1 sing-use testcartridge (cuvette) |
| StorageTemperature | 2-8°C | ✓ Substantially Equivalent2-8°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
| ControlCharacteristics | directCHECK™ Whole Blood ControlsACT+ and ACT-LR(Predicate Device – K120977) | directCHECK™ Whole Blood QualityControls(Subject Device) |
|---|---|---|
| Similarities | ||
| Intended Use | The directCHECK™ Whole Blood QualityControls are dried whole blood preparationswhich have been assayed and are intended tobe used to perform quality control assays usingthe Hemochron Microcoagulation test cuvettes.For in vitro Diagnostic Use. For ProfessionalUse, Rx Only. | ✔ Substantially EquivalentThe directCHECK™ Whole Blood QualityControls are dried whole blood preparationswhich have been assayed and are intended to beused to perform quality control assays using theHemochron test cartridges.For in vitro Diagnostic Use. For ProfessionalUse, Rx Only. |
| Preparation | Distilled Water, Sodium Chloride, Tween® 20,ProClin® and anticoagulant | ✔ Substantially EquivalentDistilled Water, Sodium Chloride, Tween® 20,ProClin® and anticoagulant |
| Packaging | 15 single use vials | ✔ Substantially Equivalent15 single use vials |
| StorageTemperature | 2-8°C | ✔ Substantially Equivalent2-8°C |
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| 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 andlaboratory use. Part 1: General requirements |
| IEC 61010-2-010 | Safety requirements for electrical equipment for measurement, control andlaboratory use - Part 2-010: Particular requirements for laboratory equipmentfor the heating of materials | |
| IEC 61010-2-101 | Safety requirements for electrical equipment for measurement, control andlaboratory 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 - EMCrequirements - Part 1: General Requirements |
| CISPR 11 | Industrial, scientific and medical equipment - Radio- frequency disturbancecharacteristics - Limits and methods of measurement | |
| IEC 61000-3-2 | Electromagnetic compatibility (EMC) – Part 3-2: Limits - Limits forharmonic current emissions | |
| IEC 61000-3-3 | Electromagnetic compatibility (EMC) - Part 3-3: Limits - Limitation ofvoltage changes, voltage fluctuations and flicker in public low - voltagesupply systems, for equipment with rated current ≤16 A per phase and notsubject 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 basicsafety and essential performance – Collateral standard: EletromagneticDisturbances - Requirements and tests |
| IEC 61000-4-2 | Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurementtechniques - Electrostatic discharge immunity test | |
| IEC 61000-4-3 | Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurementtechniques - Radiated, radio-frequency, electromagnetic field immunity test | |
| IEC 61000-4-4 | Electromagnetic compatibility (EMC) - Part 4-4: Testing and measurementtechniques - Electrical fast transient/burst immunity test | |
| IEC 61000-4-5 | Electromagnetic compatibility (EMC) - Part 4-5: Testing and measurementtechniques - Surge immunity test | |
| IEC 61000-4-6 | Electromagnetic compatibility (EMC) – Part 4-6: Testing and measurementtechniques - Immunity to conducted disturbances, induced by radio-frequency fields | |
| IEC 61000-4-8 | Electromagnetic compatibility (EMC) - Part 4-8: Testing and measurementtechniques - Power frequency magnetic field immunity test | |
| IEC 61000-4-11 | Electromagnetic compatibility (EMC) - Part 4-11: Testing and measurementtechniques - Voltage dips, short interruptions and voltage variationsimmunity tests | |
| AIM 7351731 | Medical Electrical Equipment and System Electromagnetic Immunity Testfor Exposure to Radio Frequency Identification Readers | |
| ISO 14223 | Radiofrequency identification of animals - Advanced transponders | |
| ISO/IEC 14443-3 | Identification cards - Contactless integrated circuit cards - Proximitycards - Part 3: Initialization and anticollision | |
| ISO/IEC 14443-4 | Cards and security devices for personal identification - Contactlessproximity 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 itemmanagement - Part 3: Parameters for air interface communications at 13,56MHz | |
| ISO/IEC 18000-7 | Information technology - Radio frequency identification for itemmanagement - Part 7: Parameters for active air interface communications at433 MHz | |
| ISO/IEC 18000-63 | Information technology - Radio frequency identification for itemmanagement - 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 itemmanagement — Part 4: Parameters for air interface communications at 2,45GHz | |
| FCC Part 15B§15.407 | General technical requirements |
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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 100vs HemochronTM SignatureElite | 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™ 100vs Hemochron™ SignatureElite | 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.
§ 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.