(81 days)
ASSERACHROM® D-Di
Not Found
No
The summary describes a standard in vitro diagnostic immunoassay kit and analyzer, with no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is an in vitro diagnostic (IVD) immunoassay designed for the quantitative measurement of D-Dimer in human plasma to aid in the diagnosis of thromboembolic events, not for treating them.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "used in the diagnosis of thromboembolic events."
No
The device description explicitly states it is a "set of reagents" intended for use with "OPUS immunoassay analyzers," indicating it is a hardware-dependent in vitro diagnostic (IVD) device, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "OPUS D-Dimer is an in vitro fluorogenic enzyme immunoassay (ELISA) for the quantitative measurement of cross-linked fibrin degradation products (XL-FDP) containing D-Dimer in human plasma, used in the diagnosis of thromboembolic events."
The term "in vitro" is a key indicator that the device is intended for use outside of the living body, typically on biological samples like plasma, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
OPUS D-Dimer is an in vitro fluorogenic enzyme immunoassay (ELISA) for the quantitative measurement of cross-linked fibrin degradation products (XL-FDP) containing D-Dimer in human plasma, used in the diagnosis of thromboembolic events. OPUS D-Dimer is intended for use with the OPUS analyzers.
Product codes (comma separated list FDA assigned to the subject device)
GHH
Device Description
OPUS D-Dimer is a set of reagents intended to be used together with the OPUS immunoassay analyzers for the quantitative measurement of cross-linked fibrin degradation products containing D-Dimer in human plasma.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
human plasma
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision:
Intra-assay precision was determined by the evaluation of two levels of control material in replicates of twenty (20) each. %CV ranged from 7.3% to 8.9%.
Inter-assay precision was determined by the evaluation of two levels of control material in duplicate, assayed over a five day period to total 20 replicates. %CV ranged from 8.6% to 10.3%.
Accuracy by Recovery:
Recovery was determined by spiking previously assayed and pooled human serum matrix with five different levels of D-Dimer. The samples were assayed using OPUS D-Dimer in duplicate. Percent recovery ranged from 85 to 95%.
Accuracy by Correlation:
OPUS D-Dimer was compared to a commercially available D-Dimer assay by evaluation of 321 human plasma samples ranging from 37 to 8480 ng/ml. A correlation coefficient of 0.93 was obtained, with a y-intercept value of 0.34 and a slope of 0.89.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Intra-assay %CV ranged from 7.3% to 8.9%.
Inter-assay %CV ranged from 8.6% to 10.3%.
Percent recovery ranged from 85 to 95%.
Correlation coefficient of 0.93.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
ASSERACHROM® D-Di
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 864.7320 Fibrinogen/fibrin degradation products assay.
(a)
Identification. A fibrinogen/fibrin degradation products assay is a device used to detect and measure fibrinogen degradation products and fibrin degradation products (protein fragments produced by the enzymatic action of plasmin on fibrinogen and fibrin) as an aid in detecting the presence and degree of intravascular coagulation and fibrinolysis (the dissolution of the fibrin in a blood clot) and in monitoring therapy for disseminated intravascular coagulation (nonlocalized clotting in the blood vessels).(b)
Classification. Class II (performance standards).
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Behring Diagnostics Inc. OPUS® D-Dimer 510(k) Notification
SEP 9 1997
510(k) Summary for OPUS D-Dimer
Manufactures Name, Address, Telephone, and contact person, date of 1 . preparation:
Manufacturer:
Behring Diagnostics Inc. 151 University Avenue Westwood, MA 02090 617-320-3117 Attn: Ruth Forstadt
Preparation date:
June 19, 1997
- Device Name/ Classification: 2.
OPUS D-Dimer: Classification Number:
Fibrinogen/fibrin degradation products assay Class II (864.7320)
- 3 . marketed device: Identification of the legally
ASSERACHROM® D-Di
Description: 4 . Device
OPUS D-Dimer is a set of reagents intended to be used together with the OPUS immunoassay analyzers for the quantitative measurement of cross-linked fibrin degradation products containing D-Dimer in human plasma.
5. Device Intended Use:
OPUS D-Dimer is an in vitro fluorogenic enzyme immunoassay (ELISA) for the quantitative measurement of cross-linked fibrin degradation products containing D -Dimer in human plasma. OPUS D-Dimer is intended for use with the OPUS analyzers.
CONFIDENTIAL
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Behring Diagnostics Inc. OPUS® D-Dimer 510(k) Notification
Medical device to which equivalence is claimed and comparison 6. information:
The OPUS D-Dimer assay is substantially equivalent in intended use to the ASSERACHROM® D-Di. The ASSERACHROM® D-Di, like the proposed product, employs the principle of two site or sandwich immunoassay. The OPUS D-Dimer and ASSERACHROM D-Di both quantitatively measure cross-linked fibrin degradation products that contain D-Dimer in human plasma.
The OPUS D-Dimer differs from the ASSERACHROM® D-Di in that the enzyme labeled antibody is a rabbit polyclonal in the ASSERACHROM® D-Di while the enzyme labeled antibody is a mouse monoclonal in the OPUS test. Also, the OPUS D-Dimer includes a bilevel control, where as the ASSERACHROM® D-Di test does not include a control. Additionally, the OPUS D-Dimer is used with a fully automated fluorometric instrument system which includes a stored calibration curve while the ASSERACHROM® D-Di is a manual assay and uses a calibration curve with each run. Also, the OPUS D-Dimer does not require sample pretreatment for plasma samples while the ASSERACHROM® D-Di requires a predilution of the plasma samples. EDTA, heparinized and citrated plasma samples may be used with the OPUS D-Dimer, but only citrated plasma samples with the ASSERACHROM® D-Di.
Device Performance Characteristics: 7 .
Precision
Intra-assay precision was determined by the evaluation of two levels of control material in replicates of twenty (20) each. %CV ranged from 7.3% to 8.9%.
Inter-assay precision was determined by the evaluation of two levels of control material in duplicate, assayed over a five day period to total 20 replicates. %CV ranged from 8.6% to 10.3%.
Accuracy by Recovery
Recovery was determined by spiking previously assayed and pooled human serum matrix with five different levels of D-Dimer. The samples were assayed using OPUS D-Dimer in duplicate. Percent recovery ranged from 85 to 95%.
Accuracy by Correlation
OPUS D-Dimer was compared to a commercially available D-Dimer assay by evaluation of 321 human plasma samples ranging from 37 to 8480 ng/ml. A correlation coefficient of 0.93 was obtained, with a y-intercept value of 0.34 and a slope of 0.89.
0000224
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three stylized lines.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 9 1997
Ruth Forstadt . Requlatory Affairs Associate Behring Diagnostics Inc. 151 University Avenue Westwood, Massachusetts 02090
Re : K972316 OPUS® D-Dimer Test System Regulatory Class: II Product Code: GHH Dated: June 19, 1997 Received: June 20, 1997
Dear Ms. Forstadt:
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 The general controls provisions of the Act 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. ਰ 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 action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
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 regulation (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 "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Sutman
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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Diagnostics Inc. Behring OPUS® D-Dimer 510(k) Notification
Page of
510(k) Number (if known): K972316
OPUS D-Dimer Test System
Device Name: J
Indications For Use:
OPUS D-Dimer is an in vitro fluorogenic enzyme immunoassay (ELISA) for the quantitative measurement of cross-linked fibrin degradation products (XL-FDP) containing D-Dimer in human plasma, used in the diagnosis of thromboembolic events. OPUS D-Dimer is intended for use with the OPUS analyzers
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Clinical Laboratory Devifes
510(k) Number. K972316
Prescription Use (Per 21 CFR 801.109) OR
Over-The Counter Use
(Optional Format 1-2-96)
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