(339 days)
Not Found
No
The description details a standard chromogenic assay based on chemical reactions and absorbance measurements, with no mention of AI/ML terms or concepts.
No
The device is an in vitro diagnostic assay used to quantify functionally active antithrombin, aiding in the diagnosis of antithrombin deficiency, rather than providing therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "can be used as an aid in the diagnosis of antithrombin deficiency."
No
The device description clearly outlines a chromogenic assay that utilizes reagents and measures absorbance at 405 nm, indicating a physical laboratory test involving chemical reactions and optical measurement, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's a "chromogenic assay for the automated quantitation of functionally active antithrombin in human citrated plasma and can be used as an aid in the diagnosis of antithrombin deficiency." This clearly indicates it's used to test human samples in vitro (outside the body) for diagnostic purposes.
- Device Description: The description details a laboratory test that analyzes a human sample (citrated plasma) using chemical reactions (chromogenic assay) to measure a specific substance (antithrombin). This is characteristic of an in vitro diagnostic device.
- Sample Type: The device uses "human citrated plasma," which is a biological sample taken from a human.
- Diagnostic Aid: The intended use states it's an "aid in the diagnosis," which is a key function of many IVDs.
The information provided strongly aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
INNOVANCE™ Antithrombin is a chromogenic assay for the automated quantitation of functionally active antithrombin in human citrated plasma and can be used as an aid in the diagnosis of antithrombin deficiency.
Product codes (comma separated list FDA assigned to the subject device)
JBQ
Device Description
The INNOVANCE™ Antithrombin assay utilizes a chromogenic measuring principle. An excess of factor Xa is added to citrated plasma. In the presence of heparin, a portion of the enzyme is complexed and inactivated by the antithrombin present in the sample.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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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)
Method Comparison Study: The INNOVANCE™ Antithrombin reagent was compared to the Dade Behring Berichrom™ Antithrombin III (A) reagent on the BCS®/BCS® XP System by evaluating plasma samples with antithrombin activity ranging from 4.8 to 131.3% of the norm. Regression analysis of these evaluations yielded the following equation: Comparative Method: BerichromTM Antithrombin III (A) on the BCS ® /BCS® XP System; n = 284; Slope = 1.04; Intercept = 0.34; Correlation Coefficient = 0.944.
Precision studies were conducted with the BCS®/BCS® XP System, as described in the CLSI Guideline EP5-A2, using Control Plasma N (control plasma in the normal range) and Control Plasma P (control plasma in the pathological range) as well as a pathological plasma pool (human plasma pool in the decision range).
Results: For Control Plasma N (Mean [% of the Norm] = 95.8), Repeatability CV [%] = 2.8 and Within-device/lab CV [%] = 3.7. For Control Plasma P (Mean [% of the Norm] = 31.4), Repeatability CV [%] = 2.6 and Within-device/lab CV [%] = 4.5. For Pathological Plasma Pool (Mean [% of the Norm] = 61.7), Repeatability CV [%] = 1.9 and Within-device/lab CV [%] = 3.5.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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).
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§ 864.7060 Antithrombin III assay.
(a)
Identification. An antithrombin III assay is a device that is used to determine the plasma level of antithrombin III (a substance which acts with the anticoagulant heparin to prevent coagulation). This determination is used to monitor the administration of heparin in the treatment of thrombosis. The determination may also be used in the diagnosis of thrombophilia (a congenital deficiency of antithrombin III).(b)
Classification. Class II (performance standards).
0
510(k) Summary for INNOVANCE™ Antithrombin
MAY 28 2009
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: _______________________________________________________________________________________________________________________________________________
- Manufacturer's Name, Address, Telephone, and Contact Person, Date of Preparation: 1.
Manufacturer: | Dade Behring Marburg GmbH |
---|---|
A Siemens Company | |
Emil-von-Behring Str. 76 | |
35041 Marburg, Germany |
- Siemens Healthcare Diagnostics Inc. Contact Information: 500 GBD Drive Newark, Delaware 19702 Attn: Radames Riesgo Tel: 305.480.7558 Fax: 305.552.5288
May 5. 2009 Preparation date:
INNOVANCE™ Antithrombin 2. Device Name:
Class II Classification: Product Code: JBQ Panel: Hematology
3. Identification of the Legally Marketed Device:
Dade Behring Berichrom™ Antithrombin III (A) - K933125
Device Description: 4.
The INNOVANCE™ Antithrombin assay utilizes a chromogenic measuring principle. An excess of factor Xa is added to citrated plasma. In the presence of heparin, a portion of the enzyme is complexed and inactivated by the antithrombin present in the sample. Excess, uninhibited factor Xa then cleaves a specific chromogenic substrate, causing the release of a dye. The rate of the substrate cleavage is determined by the increase in the absorbance value at 405 nm.
-> [antithrombin · heparin] antithrombin + heparin -[antithrombin · heparin] + FXa (excess) —> [antithrombin · heparin · FXa] + FXa (residual)
FXa (residual)
chromogenic FXa substrate ----------- > tripeptide + dye
1
The release of dye is inversely proportional to the inhibiting activity of the antithrombin in the plasma sample, i.e. the smaller the concentration of functionally active antithrombin, the higher the absorbance signal per time unit.
5. Device Intended Use:
INNOVANCE™ Antithrombin is a chromogenic assay for the automated quantitation of functionally active antithrombin in human citrated plasma and can be used as an aid in the diagnosis of antithrombin deficiency.
Medical device to which equivalence is claimed and comparison information: 6.
The INNOVANCE™ Antithrombin reagent is substantially equivalent, and has the same intended use and performance to the Dade Behring Berichrom™ Antithrombin III (A) reagent (K933125).
7. Device Performance Characteristics:
The INNOVANCE™ Antithrombin reagent was compared to the Dade Behring Berichrom™ Antithrombin III (A) reagent on the BCS®/BCS® XP System by evaluating plasma samples with antithrombin activity ranging from 4.8 to 131.3% of the norm. Regression analysis of these evaluations yielded the following equation:
Comparative Method | n | Slope | Intercept | Correlation Coefficient |
---|---|---|---|---|
BerichromTM Antithrombin III (A) on the BCS ® /BCS® XP System | 284 | 1.04 | 0.34 | 0.944 |
Method Comparison Study
Precision studies were conducted with the BCS®/BCS® XP System, as described in the CLSI Guideline EP5-A2, using Control Plasma N (control plasma in the normal range) and Control Plasma P (control plasma in the pathological range) as well as a pathological plasma pool (human plasma pool in the decision range).
Sample | Precision (N = 80) | ||
---|---|---|---|
Mean | |||
[% of the Norm] | Repeatability CV | ||
[%] | Within-device/lab CV | ||
[%] | |||
Control Plasma N | 95.8 | 2.8 | 3.7 |
Control Plasma P | 31.4 | 2.6 | 4.5 |
Pathological | |||
Plasma Pool | 61.7 | 1.9 | 3.5 |
8. Conclusion:
The proposed INNOVANCE™ Antithrombin device is substantially equivalent to the legally marketed device based upon the correlation studies and the information above.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is rendered in black and white, providing a clear and recognizable representation of the HHS.
Public Health Service
28 2009 MAY
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Siemens Healthcare Diagnostics Inc. c/o Mr. Radames Riesgo Regulatory Affairs and Compliance Manager 500 GBD Drive MS 514 Newark, DE 19702
Re: K081769
Trade/Device Name: INNOVANCE™ Antithrombin Regulation Number: 21 CFR 864.7060 Regulation Name: Antithrombin III assay Regulatory Class: Class II Product Code: JBQ Dated: March 23, 2009 Received: March 24, 2009
Dear Mr. Riesgo:
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, 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 (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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice
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Page 2 - Mr. Radames Riesgo
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours,
・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
ie m. chan
Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
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、
Enclosure
4
Indications for Use
510(k) Number (if known): K081769
Device Name: INNOVANCE™ Antithrombin
Indications for Use:
INNOVANCE™ Antithrombin is a chromogenic assay for the automated quantitation of functionally active antithrombin in human citrated plasma and can be used as an aid in the diagnosis of antithrombin deficiency.
Prescription Use _ X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
RemelD
Division Sign-Off
Office of In Vitro Diagnostic
Device Evaluation and Safety
K081769
510(k)