(19 days)
The HEMOCHRON ® Response is intended for professional use for hemostasis management in a variety of clinical settings for the quantitative determination of an assortment of coagulation test assays including the following HEMOCHRON Whole Blood Coagulation Assays Activated Clotting Time (ACT) - All HEMOCHRON types Activated Partial Thromboplastin Time (APTT) - All HEMOCHRON types Prothrombin Time (PT) - All HEMOCHRON types Thrombin Time (TT) Heparin Neutralized Thrombin Time (HNTT) High Dose Thrombin Time (HiTT) Fibrinogen (FIB) Protamine Dose Assay (PDA) - All HEMOCHRON types Heparin Response Time (HRT) - All HEMOCHRON types Protamine Response Time (PRT) - All HEMOCHRON types For In Vitro Diagnostic Use Only
The Hemochron Response instrument/system described herein is a software upgrade (Version 2.0) to the current Hemochron Response Instrument, which has been cleared under K983475 (May 1999). The HEMOCHRON® Response is a portable, dual-well microprocessor-controlled coagulation instrument with an integral barcode reader, laboratory communication interface and a printer designed to perform whole blood coagulation tests using fresh or citrated whole blood. The system is intended for use in many clinical settings requiring point-of-care testing. The modified Response instrument performs the same assays as the predicate instrument. There are no changes to the clot detection algorithm. The patented clot detection mechanism is an electro-mechanical system consisting of two test wells into which disposable test tube assays are inserted. The test tube assays contain specific reagent for the test performed and a precision magnet. Immediately after adding a blood sample to the test tube and pressing the start button, the test tube is placed in the test well and is automatically rotated at a slow controlled speed and incubated at 37°C. When a fibrin clot begins to form, it causes the magnet in the test tube to be displaced. Two magnetic detectors located in the test well continuously monitor the precise position of the magnet. When a pre-determined displacement occurs, the elapsed time form the start of the test and the clot endpoint is displayed as the coagulation time in seconds.
The provided document describes a 510(k) submission for a software upgrade (Version 2.0) to the HEMOCHRON® Response Instrument/System, which is a whole blood coagulation test system. The study compares the performance of the new version (V2.00) with the predicate device (V1.52) to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and the study, structured according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in a numerical or threshold format. Instead, it demonstrates equivalence to a predicate device, implying that the new device's performance is acceptable if it is comparable to the established predicate. The performance is assessed through linear correlation for accuracy and precision (CV%) for reproducibility.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance (HR V2.00 vs HR V1.52) |
|---|---|---|
| Linear Correlation (Accuracy) | Strong linear correlation ($r \ge 0.95$) between new and predicate device measurements for various assay groups. | ACT Tubes: $y=0.98x-9.36$, $r=0.995$ |
| Specialty Tubes: $y=1.04x-0.45$, $r=0.954$ | ||
| RxDx Tubes: $y=1.00x-16.32$, $r=0.998$ | ||
| Precision (Reproducibility) | Comparable Coefficient of Variation (CV%) between new and predicate device measurements for various assays and control levels. | ACT: Level 1 CV% (V2.00: 6.0%, V1.52: 6.2%), Level 2 CV% (V2.00: 5.1%, V1.52: 3.4%) |
| APTT FWB: Level 1 CV% (V2.00: 7.5%, V1.52: 8.5%), Level 2 CV% (V2.00: 5.3%, V1.52: 5.2%) | ||
| PRT: Level 1 CV% (V2.00: 5.1%, V1.52: 5.6%), Level 2 CV% (V2.00: 4.2%, V1.52: 2.7%) | ||
| HiTT: Level 1 CV% (V2.00: 14.4%, V1.52: 13.5%), Level 2 CV% (V2.00: 15.7%, V1.52: 13.0%) |
Note: The phrase "The linear correlations between the instruments were excellent" explicitly supports the device meeting the implied acceptance criterion for accuracy. For precision, the CV% values for V2.00 are generally very similar to or slightly better/worse than V1.52, indicating comparable reproducibility.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set (Accuracy/Correlation Studies):
- Sample Size:
- ACT Tubes: 18 (n=18)
- Specialty Tubes: 15 (n=15)
- RxDx Tubes: 17 (n=17)
- Data Provenance: Blood samples were drawn from "four different donors and heparinized in vitro." This suggests controlled laboratory conditions. The country of origin is not specified but implicitly US, given the FDA submission. The data is prospective for the purpose of this submission, as it was generated specifically to compare V2.00 and V1.52.
- Sample Size:
- Test Set (Precision Studies):
- Sample Size: "n=10 per instrument type" (2 V1.52 and 2 V2.00 instruments) for each of two control levels per assay. This means 10 measurements per instrument per control level, totaling 20 measurements per assay per instrument type (e.g., for ACT, 20 for V2.00 and 20 for V1.52 at each control level).
- Data Provenance: Laboratory studies using assay-specific controls. Implicitly US, prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document does not describe studies needing expert adjudication or ground truth establishment in the way typically seen for image analysis or diagnostic interpretation by human experts. The "ground truth" in this context is the measurement provided by a predicate device (HEMOCHRON® Response V1.52) and highly controlled, standardized laboratory controls. Therefore, no human experts are mentioned for establishing ground truth for the test set.
4. Adjudication Method for the Test Set
Not applicable. The study involves direct comparison of instrument measurements (new vs. predicate, or new vs. its own repeated measurements for precision) rather than human interpretation requiring adjudication.
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 not a study comparing human reader performance with or without AI assistance. It’s a comparison of two versions of an automated coagulation instrument.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The studies presented are standalone in the sense that they evaluate the performance of the instrument (V2.00) itself, comparing its measurements to a predicate instrument (V1.52) or against laboratory controls. There is no human-in-the-loop performance evaluated or described in these specific performance studies. The system is designed for professional use, but the reported performance data focuses solely on the device's measurement capabilities.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For Accuracy/Correlation Studies: The ground truth is established by the measurements from the predicate device (HEMOCHRON® Response V1.52). The goal is to show the new version correlates well with the previously cleared and accepted device.
- For Precision Studies: The ground truth is the assigned value of the assay-specific controls, against which the instrument's reproducibility is measured.
8. The Sample Size for the Training Set
This document does not describe a machine learning algorithm or a new diagnostic model that requires a training set. The changes primarily involve a software upgrade to activate existing functionalities (like the RxDx module) and enhance user programming, not to develop a new analytical algorithm. Therefore, there is no training set mentioned or applicable in this context.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set is described.
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510 (k) Summary
HEMOCHRON® Response Instrument/System
March 13, 2003 Prepared:
Submitted by: John Clay International Technidyne Corp. 6 Olsen Ave. Edison, NJ 08820 (732-548-5700) Ext. 265 (732-548-2325) Fax
This summary of safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Device Name
| Common / Usual Name: | Whole Blood Coagulation Test System |
|---|---|
| Product Name: | HEMOCHRON® Response Instrument/System |
Predicate Device
HEMOCHRON® Response (K983475)
Device Description
The Hemochron Response instrument/system described herein is a software upgrade (Version 2.0) to the current Hemochron Response Instrument, which has been cleared under K983475 (May 1999).
The HEMOCHRON® Response is a portable, dual-well microprocessor-controlled coagulation instrument with an integral barcode reader, laboratory communication interface and a printer designed to perform whole blood coagulation tests using fresh or citrated whole blood. The system is intended for use in many clinical settings requiring point-of-care testing. The modified Response instrument performs the same assays as the predicate instrument. There are no changes to the clot detection algorithm.
The patented clot detection mechanism is an electro-mechanical system consisting of two test wells into which disposable test tube assays are inserted. The test tube assays contain specific reagent for the test performed and a precision magnet. Immediately after adding a blood sample to the test tube and pressing the start button, the test tube is placed in the test well and is automatically rotated at a slow controlled speed and incubated at 37°C. When a fibrin clot begins to form, it causes the magnet in the test tube to be displaced. Two magnetic detectors located in the test well continuously monitor the precise position of the magnet. When a pre-determined displacement occurs, the elapsed time form the start of the test and the clot endpoint is displayed as the coagulation time in seconds.
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The HEMOCHRON® Response contains extensive data management capabilities including the following:
- Patient and quality control result storage
- . Input of operator and patient identification
- Designation of quality control level ●
- Date and time stamp for all test results .
- Printing of results
- . Tagging of test results with date and time
- Operator Lockout ●
- Storage of operator identification numbers .
- . Downloading of stored patient and OC data to a PC
- Configurable date and time formats
New Features of the Hemochron Response Instrument
The modifications to the Hemochron Response instrument include a software revision to the instrument. The major components of the software modification include the following:
- . Activation of the automated heparin and protamine dosing calculations for patient management. This system is the RxDx module and is described in a previous submission (K010193) for the Hemochron Kaolin-Activated heparin and protamine dosing assays.
- Enhanced programming capability and flexibility for the user through the use of the . instrument keypad and the Hemochron Response Data Management Software (HRDM), which is provided for use in a personal computer (PC). The use of the Hemochron Response Data Management Software has been described in the predicate device submission and operator's manual (K983475).
The user interface for the clinician remains consistent with the previously cleared system with the exception of the enhanced features described in the revised operators manual, the RxDx module and the features associated with the (HRDM).
Statement of Intended Use
The HEMOCHRON ® Response is intended for professional use for hemostasis management in a variety of clinical settings for the quantitative determination of an assortment of coagulation test assays including the following HEMOCHRON Whole Blood Coagulation Assays for In vitro diagnostic use only.
Activated Clotting Time (ACT) - All HEMOCHRON types Activated Partial Thromboplastin Time (APTT) - All HEMOCHRON types Prothrombin Time (PT) - All HEMOCHRON types Thrombin Time (TT) Heparin Neutralized Thrombin Time (HNTT) High Dose Thrombin Time (HiTT) Fibrinogen (FIB) Protamine Dose Assay (PDA) - All HEMOCHRON types Heparin Response Time (HRT) - All HEMOCHRON types Protamine Response Time (PRT) - All HEMOCHRON types
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Summary of Performance Data
Laboratory Correlations
Laboratory correlation studies were conducted between the Hemochron Response V1.52 (Current Version) and Hemochron Response V2.00 (Modified Version) instruments using a split sample design. Heparin sensitivity testing was conducted on the test tubes from each of three groups of tests, namely ACT (including ACT, KACT and P214), specialty tubes (including APTT FWB, APTT Citrate, PT FWB, PT Citrate, TT, HNTT, Fibrinogen diluted and undiluted) and RxDx tubes (including HRTB, HRTP, PDAO, PRT200, each in Celite or kaolin versions). Blood samples were drawn from four different donors and heparinized in vitro. Six HR V2.00 and six HR V1.52 were used for these laboratory studies.
The linear correlations between the instruments were excellent. (Y=HR V2.00, X=HR V1.52) HR=Hemochron Response
| Test Assay Group | Correlation Equation | r value | n |
|---|---|---|---|
| ACT Tubes | $y=0.98x-9.36$ | 0.995 | 18 |
| Specialty Tubes | $y=1.04x-0.45$ | 0.954 | 15 |
| RxDx Tubes | $y=1.00x-16.32$ | 0.998 | 17 |
Precision Testing
Precision testing was conducted using two levels of assay-specific controls on two Response V 1.52 and two Response V2.00 (n=10 per instrument type) instruments. Representative assays from each of three groups of tests including ACT (ACT test tubes), APTT Fresh Whole Blood, HiTT (Specialty test tubes) and PRT (RxDx test tubes) were used in the test matrix.
| Level 1 | HR V2.00 | HR V1.52 | Level 2 | HR V2.00 | HR V1.52 |
|---|---|---|---|---|---|
| total mean | 127.5 | 130.8 | total mean | 269.3 | 261.8 |
| SD | 7.6 | 8.1 | SD | 13.8 | 9.0 |
| CV% | 6.0% | 6.2% | CV% | 5.1% | 3.4% |
| mean diff | 2.52% | mean diff | 2.86% |
d. CDI Na ారా (Control
Assay: APTT FWB (Control used: O101 Normal and Abnormal)
| Level : | HR V2.00 | HR V 1.52 | Level 2 | HR V2.00 | HR V1.52 | |
|---|---|---|---|---|---|---|
| total mean | 103.5 | 106.6 | total mean | 335.6 | 321.9 | |
| SD | 7.8 | 9.1 | SD | 17.9 | 16.9 | |
| CV% | 7.5% | 8.5% | CV% | 5.3% | 5.2% | |
| mean diff | 2.91% | mean diff | 4.26% |
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| Assay: PRT | (Control used: RxDX WBC Normal and PRT Level II) | ||||
|---|---|---|---|---|---|
| Level 1 | HR V2.00 | HR V1.52 | Level 2 | HR V2.00 | HR V1.52 |
| total mean | 151.8 | 156.5 | total mean | 359.5 | 376.4 |
| SD | 7.7 | 8.8 | SD | 14.9 | 10.3 |
| CV% | 5.1% | 5.6% | CV% | 4.2% | 2.7% |
| mean diff | 3.51% | mean diff | 4.49% |
Assav: PRT (Control used: PxDx WRC Normal and PPT Lavel II)
Assay: HiTT
(Control used: RxDx WBC Normal and HiTT Level II)
| Level 1 | HR V2.00 | HR V1.52 | Level 2 | HR V2.00 | HR V1.52 | |
|---|---|---|---|---|---|---|
| total mean | 57.1 | રેતે રહ્યું રેતા વિ | total mean | 168.6 | 183.9 | |
| SD | 8.2 | 8.0 | SD | 26.4 | 24.0 | |
| CV% | 14.4% | 13.5% | CV% | 15.7% | 13.0% | |
| mean diff | 4.19% | mean diff | 8.32% | |||
Conclusion of Risk analysis and Design Controls
Based on the extensive verification and validation testing, it can be concluded that the potential risks associated with the modified system have been resolved and that safety and effectiveness of the HEMOCHRON Response Instrument/System are not compromised.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized caduceus-like symbol with three intertwined lines, representing health and medicine. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. John Clay Director, Regulatory Affairs International Technidyne Corporation 8 Olsen Avenue Edison, New Jersey 08820
Re: K030818
Trade/Device Name: HEMOCHRON® Response Instrument/System Regulation Number: 21 CFR & 864.5425 Regulation Name: Multipurpose System for In Vitro Coagulation Instruments Regulatory Class: II Product Code: JPA Dated: March 13. 2003 Received: March 14, 2003
APR 0 2 2003
Dear Mr. Clay:
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. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
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Page 2 -
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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510(k) Number (If Known):
Device name: HEMOCHRON® Response
Indications for Use:
The HEMOCHRON ® Response is intended for professional use for hemostasis management in a variety of clinical settings for the quantitative determination of an assortment of coagulation test assays including the following HEMOCHRON Whole Blood Coagulation Assays
Activated Clotting Time (ACT) - All HEMOCHRON types Activated Partial Thromboplastin Time (APTT) - All HEMOCHRON types Prothrombin Time (PT) - All HEMOCHRON types Thrombin Time (TT) Heparin Neutralized Thrombin Time (HNTT) High Dose Thrombin Time (HiTT) Fibrinogen (FIB) Protamine Dose Assay (PDA) - All HEMOCHRON types Heparin Response Time (HRT) - All HEMOCHRON types Protamine Response Time (PRT) - All HEMOCHRON types
For In Vitro Diagnostic Use Only
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Josephine Bautista
(Division Sign Off)
Division of Clinical Laboratory Devices
510(k) Number K030818
Prescription Use or Over-the- Counter Use
Per 21 CFR 801.109
(Optional Format 1-2-96)
§ 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.