(197 days)
No
The description focuses on mechanical-optical clot detection and regression analysis for correlated values, with no mention of AI or ML terms or concepts.
No
The device is a diagnostic instrument that performs whole blood coagulation tests, not a device used for treating a disease or condition.
Yes
The device performs "whole blood coagulation tests" and provides "test results" to "diagnose" clotting in patients.
No
The device description explicitly details a "microcoagulation instrument" with a "clot detection mechanism" that is a "combination mechanical-optical system" using "LED detectors." This clearly indicates the presence of hardware components beyond just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is designed to "perform whole blood coagulation tests using fresh whole blood at the point-of-care." This involves analyzing a biological sample (whole blood) outside of the body to provide information about a physiological state (blood coagulation).
- Device Description: The description details how the device interacts with the blood sample, including the use of reagents and a clot detection mechanism. This further confirms that it is performing a diagnostic test on a biological specimen.
- Clinical Setting: The intended use mentions "numerous clinical settings requiring point-of-care testing," which is a common application for IVD devices used for immediate diagnostic information.
The core function of the device is to analyze a biological sample (whole blood) to provide diagnostic information (coagulation times), which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The portable, battery operated HEMOCHRON® Jr. Generation II and Signature are microcoagulation instruments designed to perform whole blood coagulation tests using fresh whole blood at the point-of-care. The system is intended to be used in numerous clinical settings requiring point-of-care testing. Test results are displayed as whole blood test results and plasma equivalent values, in seconds. For the ACT, the instrument also displays correlated celite equivalent values. The APTT and PT correlated values are based on regression analyses of comparative whole blood/plasma studies.
The portable, battery operated HEMOCHRON® JR. SIGNATURE is a microcoagulation instrument designed to perform whole blood coagulation tests using fresh whole blood at the patient bedside. The system is intended to be used in many clinical settings requiring point-of-care testing. Whole blood test results are displayed as clotting times, in seconds. The instrument also displays correlated celite equivalent values. The correlated values are based on regression analyses of comparative whole blood/plasma studies.
Product codes
JPA
Device Description
The Generation II system performs the same tests as the predicate Jr. system, APTT, PT, ACT+, and ACT-LR with the same end point detection system. All assays are intended to be performed at point of care (POC). Blood is placed in a collection reservoir of the test cuvette and automatically sampled into a test channel which contains reagents required to perform the respective assay. Excess blood is drawn into a waste cuvette. The clot detection mechanism is a combination mechanical-optical system. As blood is actively pumped back and forth in the test channel, two LED detectors measure the position of the blood. As clotting occurs, the movement of the blood decreases below a pre-determined rate and an endpoint is recorded. Test results for the APTT and PT are displayed as whole blood clotting times and plasma equivalent times. Test results for the ACT+ and ACT-LR are displayed as traditional HEMOCHRON® celite ACT values.
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
Not Found
Intended User / Care Setting
point-of-care, numerous clinical settings requiring point-of-care testing, patient bedside
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
0
197479999999999999999999999999999999999999999999999999999999999999999999999999999999999999999999999999999999999999999999999999999999999999999999999999999999999999999999999999
INTERNATIONAL
TECHNIDYNE
JUL 7 1998
8 Olsen Avenue ▼ Edison, NJ 08820 Toll Free Phone: (800) 631-5945 CORPORATION Phone: (732) 548-5700 FAX: (732) 632-9299
510 (k) SUMMARY
Prepared: 1/19/98
Submitted by: Robert Matland International Technidyne Corp. 23 Nevsky St. Edison, N.J. 08820 Office: (732) 548-5700 X-248 Fax: (732)548-2419
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is K974799.
Device Name
| Common/Usual Name: | HEMOCHRON® Jr. Generation II
Microcoagulation System |
| -------------------- | --------------------------------------------------------- |
|---|
Product Name: HEMOCHRON® Jr. Generation II HEMOCHRON® Jr. Signature
Predicate Device
International Technidyne Corp. HEMOCHRON® Jr. Microcoagulation System which was approved under 510 (k) K923761/A (APTT only, January 21, 1993) and K940401 (multiple assay use May 11, 1994) ,
Device Description
The Generation II system performs the same tests as the predicate Jr. system, APTT, PT, ACT+, and ACT-LR with the same end point detection system. All assays are intended to be performed at point of care (POC). Blood is placed in a collection reservoir of the test cuvette and automatically sampled into a test channel which contains reagents required to perform the respective assay. Excess blood is drawn into a waste cuvette. The clot detection mechanism is a combination mechanical-optical system. As blood is actively pumped back and forth in the test channel, two LED detectors measure the position of the blood. As clotting occurs, the movement of the blood decreases below a pre-determined rate and an endpoint is recorded. Test results for the APTT and PT are displayed as whole blood clotting times and plasma equivalent times. Test results for the ACT+ and ACT-LR are displayed as traditional HEMOCHRON® celite ACT values.
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Statement of Intended Use
The portable, battery operated HEMOCHRON® Jr. Generation II and Signature are microcoagulation instruments designed to perform whole blood coagulation tests using fresh whole blood at the point-of-care. The system is intended to be used in numerous clinical settings requiring point-of-care testing. Test results are displayed as whole blood test results and plasma equivalent values, in seconds. For the ACT, the instrument also displays correlated celite equivalent values. The APTT and PT correlated values are based on regression analyses of comparative whole blood/plasma studies.
Summary of Technological Characteristics
The upgrade for which this 510(k) is intended is the incorporation into the Generation II system of advanced program capability and interface capability with a PC(personal computer). These features allow the user to execute a number of software functions which specifically:
- Allow users to screen the test operators and provide or 1. limit system access. This is provided in response to clinical user's desire to monitor quality assurance and execute specific operator lockout.
- Allow users to input specific performance ranges into the 2. device for specific assays. With this feature users are able to utilize institution-specific correlations of the HEMOCHRON® Jr. POC test (i.e., APTT or PT) to the local laboratory.
-
- Allow users to download data from the individual systems to a computer system.
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Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol. The text is in all caps and is evenly spaced around the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
7 1998 . IUL
Robert Matland . Compliance Officer International Technidyne Corporation 8 Olsen Avenue Edison, New Jersey 08820
K974799 Re : HEMOCHRON® Jr. Generation II, HEMOCHRON® Jr. Signature Requlatory Class: II Product Code: JPA Dated: April 23, 1998 Received: May 12, 1998
Dear Mr. Matland:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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, listing 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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This letter will allow you to begin marketing your device as described in your 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. If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "dsmo@fdadr.cdrh.fda.gov".
Sincerely yours,
Steven Autman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/3 description: The image shows a handwritten abbreviation or initialism, "VPD," in a bold, slightly slanted font. The letters are connected, with the "V" and "P" sharing a common stroke. The "D" is formed by a vertical line and a curved line that encloses the right side of the letter. The overall impression is that the letters were written quickly and with a thick marker or pen.
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510 (k) Number (if known) : K974799
HEMOCHRON® JR. GENERATION II Device Name : HEMOCHRON® JR. SIGNATURE
Indications For Use:
The portable, battery operated HEMOCHRON® JR. SIGNATURE is a microcoagulation instrument designed to perform whole blood coagulation tests using fresh whole blood at the patient bedside. The system is intended to be used in many clinical settings requiring point-of-care testing. Whole blood test results are displayed as clotting times, in seconds. The instrument also displays correlated celite equivalent values. The correlated values are based on regression analyses of comparative whole blood/plasma studies.
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number 974799
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)