(369 days)
Not Found
No
The device description and performance studies focus on the calibration and verification of a coagulation system using certified plasma calibrators. There is no mention of AI or ML in the text, and the performance metrics are standard statistical measures for analytical performance, not AI/ML specific metrics.
No
This device is an in vitro diagnostic calibrator used for laboratory testing, not for directly treating a condition or disease.
No
Explanation: The device is a calibrator set used to establish the local PT/INR calibration and verify an INR system. It is not used to diagnose a patient's condition directly.
No
The device description explicitly states that the device is a "set of certified plasmas," which are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states that the device is intended for "plasma based procedures". The "Device Description" further clarifies that it is a "set of certified plasmas". These descriptions clearly indicate that the device is used to test samples taken from the human body (plasma) outside of the body, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
PT-Multi Calibrator is intended as a calibrator set for local PT/INR calibration and/or local verification of the INR system for plasma based procedures with designated Siemens thromboplastins Dade® Innovin® or Thromborel® S on the BCS® / BCS® XP Systems.
Product codes (comma separated list FDA assigned to the subject device)
GGN, JIS
Device Description
PT-Multi Calibrator is a set of certified plasmas for local PT/INR calibration and/or local verification of the INR system for plasma based procedures using Siemens Dade® Innovin® or Thromborel® S reagents on Siemens BCS® Coaguiation Systems.
The calibrator levels are manufactured using a combination of normal and depleted human plasma.
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
Not Found
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)
Method Comparison studies were conducted at three different sites using at least two lots of PT-Multi Calibrator and the conventional local ISI/MNPT. Precision was evaluated at three different sites with at least two lots of PT-Multi Calibrator.
Method Comparison Study Results (Regression Analysis)
- Denver, Thromborel S:
- Lot 37591: y=0.95x -0.00 (n=138 without extrapolation), y=0.95x -0.00 (n=139 with extrapolation)
- Lot 37592: y=0.92x +0.06 (n=136 without extrapolation), y=0.92x+0.06 (n=139 with extrapolation)
- Lot 37591 (Innovin): y=0.97x -0.10 (n=136)
- Lot 37592 (Innovin): y=0.97x -0.03 (n=130)
- Munich, Thromborel S:
- Lot 37591: y= 0.97x -0.02 (n=118 without extrapolation), y= 0.97x -0.02 (n=123 with extrapolation)
- Lot 37592: y= 0.93x +0.06 (n=118 without extrapolation), y= 0.93x +0.05 (n=123 with extrapolation)
- Lot 37591 (Innovin): y= 1.10x -0.20 (n=106)
- Lot 37592 (Innovin): y= 1.09x -0.13 (n=102)
- Marburg, Thromborel S:
- Lot 37591: y=0.92x +0.05 (n=118 without extrapolation), y=0.92x +0.05 (n=122 with extrapolation)
- Lot 38585: y=1.02x + 0.01 (n=110 without extrapolation), y=1.03x + 0.00 (n=121 with extrapolation)
- Lot 37591 (Innovin): y=0.94x -0.02 (n=112)
- Lot 38585 (Innovin): y=0.98x -0.02 (n=107)
- All sites, Thromborel S:
- Lots 37591, 37592, 38585: y=0.93x+0.03 (n=738 without extrapolation), y=0.94x+0.03 (n=768 with extrapolation)
- All sites, Innovin:
- Lots 37591, 37592, 38585: y=0.97x-0.04 (n=693)
20 Day ANOVA Precision Studies on the BCS System:
- Denver: Includes Mean (INR), Repeatability %, Within-day-CV %, Between-run-CV %, Between-day CV %, Within-device-CV % for various lots of Innovin and Thromborel S.
- Munich: Includes Mean (INR), Repeatability %, Within-day-CV %, Between-run-CV %, Between-day CV %, Within-device-CV % for various lots of Innovin and Thromborel S.
- Marburg: Includes Mean (INR), Repeatability %, Within-day-CV %, Between-run-CV %, Between-day CV %, Within-device-CV % for various lots of Innovin and Thromborel S.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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).
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
510(k) Premarket Notification K093848 PT-Multi Calibrator Additional Information November 2010 Page 56 of 60
Attachment 5
DEC 2 0 2010 510(k) Summary of Safety and Effectiveness PT-Multi Calibrator
The device name, including both the trade or proprietary name and the common or usual (a) name and the classification name of the device.
| Trade or proprietary name: | PT-Multi Calibrator |
|---|---|
| Common or usual name: | Calibrators |
| Classification name: | Multipurpose System for In Vitro Coagulation Studies (21CFR 864.5425) |
(b) The establishment registration number, if applicable, of the owner or operator submitting the premarket notification submission.
| Establishment Registration Numbers: | Site Activity |
|---|---|
| 9610806 | Manufacturer: |
| Siemens Healthcare Diagnostics Marburg GmbH | |
| Emil-von-Behring Str. 76 | |
| 35041 Marburg, Germany | |
| 2517506 | Distributor/Applicant: |
| Siemens Healthcare Diagnostics Inc. | |
| Glasgow Site | |
| Bldg. 500, M.S. 514 | |
| P.O. Box 6101 | |
| Newark, Delaware 19714-6101 |
The class in which the device has been put under Section 513 of the Act and, if known. its (c) appropriate panel: or, if the owner or operator determines that the device has not been classified under such section, a statement of the determination and the basis for the person's determination that the device is not so classified.
Class: II Panel: Hematology Product Code: GGN
Action taken by the person required to register to comply with the requirements of the Act (d) under Section 514 for performance standards.
To date, no performance standards have been finalized for this device.
Device Description (e)
PT-Multi Calibrator is a set of certified plasmas for local PT/INR calibration and/or local verification of the INR system for plasma based procedures using Siemens Dade® Innovin® or Thromborel® S reagents on Siemens BCS® Coaguiation Systems.
The calibrator levels are manufactured using a combination of normal and depleted human plasma.
1
510(k) Premarket Notification K093848 PT-Multi Calibrator Additional Information November 2010 Page 57 of 60
(f) Device Intended Use
PT-Multi Calibrator is intended as a calibrator set for local PT/NR calibration and/or local verification of the INR system for plasma based procedures with designated Siemens thromboplastins Dade® Innovin® or Thromborel® S on the BCS® / BCS® XP Systems.
A statement indicating the device is similar to and/or different from other products of (g) comparable type in commercial distribution, accompanied by data to support the statement. This information may include an identification of similar products, materials, design considerations, energy expected to be used or delivered by the device, and a description of the operational principles of the device.
The PT-Multi Calibrator is substantially equivalent in intended use to HemoslL INR Validate®, HemosIL®-ISI Calibrate, ISI web Software (K090563), Instrumentation Laboratories Co., Lexington, MA 02421. Both devices are intended as calibrators for monitoring the accuracy and control of oral anticoagulant therapy.
Suitability of this Device is supported by the data provided below (e)
Method Comparison studies were conducted at three different sites using at least two lots of PT-Multi Calibrator and the conventional local ISI/MNPT. Precision was evaluated at three different sites with at least two lots of PT-Multi Calibrator. Results of the studies are summarized in the tables below.
| BCS System | ||||||||
|---|---|---|---|---|---|---|---|---|
| without extrapolation | with extrapolation | |||||||
| (factor 1.2) | ||||||||
| Local Test System | MNPT | ISI | PT Multi Calibrator (lot #) | |||||
| Local INR Calibration | n | Regression Analysis | n | Regression Analysis | ||||
| Denver | Thromborel S | |||||||
| lot 545197 | 10,9 | 1,12 | 37591 | 138 | $y=0.95x -0.00$ | 139 | $y=0.95x -0.00$ | |
| Innovin | ||||||||
| lot 536999 | 8,4 | 0,92 | 37592 | 136 | $y=0.92x +0.06$ | 139 | $y=0.92x+0.06$ | |
| 37591 | 136 | $y=0.97x -0.10$ | N/A | N/A | ||||
| 37592 | 130 | $y=0.97x -0.03$ | N/A | N/A | ||||
| Munich | Thromborel S | |||||||
| lot 545116 | 11,5 | 1,12 | 37591 | 118 | $y= 0.97x -0.02$ | 123 | $y= 0.97x -0.02$ | |
| 37592 | 118 | $y= 0.93x +0.06$ | 123 | $y= 0.93x +0.05$ | ||||
| Innovin | ||||||||
| lot 536997 | 8,7 | 0,92 | 37591 | 106 | $y= 1.10x -0.20$ | N/A | N/A | |
| 37592 | 102 | $y= 1.09x -0.13$ | N/A | N/A | ||||
| Marburg | Thromborel S | |||||||
| lot 545248 | 12,2 | 1,05 | 37591 | 118 | $y=0.92x +0.05$ | 122 | $y=0.92x +0.05$ | |
| 38585 | 110 | $y=1.02x + 0.01$ | 121 | $y=1.03x + 0.00$ | ||||
| Innovin | ||||||||
| lot 539126 | 8,4 | 0,93 | 37591 | 112 | $y=0.94x -0.02$ | N/A | N/A | |
| 38585 | 107 | $y=0.98x -0.02$ | N/A | N/A | ||||
| all sites | Thromborel S | 37591, 37592,38585 | 738 | $y=0.93x+0.03$ | 768 | $y=0.94x+0.03$ | ||
| Innovin | 37591, 37592,38585 | 693 | $y=0.97x-0.04$ | N/A | N/A |
2
510(k) Premarket Notification K093848 PT-Multi Calibrator
Additional Information November 2010 Page 58 of 60
| 20 Day ANOVA Precision Studies on the BCS System | |||||||
|---|---|---|---|---|---|---|---|
| Denver | Local Test System | PATMUTH 36 by of B7591 | Par Mith Calbrator Dr 37592 | ||||
| Innovin lot 536999 Thromborel S lot 545197 | Innovin lot 536999 Thromborel S lot 545197 | Sinnovin lot 536999 Thromborel S lot 545197 | |||||
| CPP C2 NPP PPP CPP CPP C2 NPPLPPP | CPP C2 NPB PPP CPP C2 NPP PPP | CRRIC2 NPB PPP CPP CPP C22 NPR PPP | |||||
| Mean (INR) | 12:11 3.0 21 0 4.0 2.4 3.7 1.0 3.6 | 2:0 2.8 2.8 2.4 2.4 -3.6 -11.0 3.6 | 22 13 12 3 8 3 8 2 3 6 1 0 1 3 6 11 0 1 3 5 | ||||
| Repeatability % | 17781113 32 108837 113 | ||||||
| 1-2 0.9 | 18 11 2 10 8 1 37 1 1 3 1 1 2 0.9 | 1.8. 11.11 1 2 - 2 10.8 3.6 13.6 1.0 1.0.9 | |||||
| Within-day-CV % | 17 18 5 5 2 2 2 3 7 1 1 6 | ||||||
| 1.7 1.5 | 118 81.5 5 5 5 8 8 8 6 1 6 1 1 6 1 1 .6 1 1 5 | 1.8 1.5 11.5 11:51 3.8 1.5 1.5 1.5 1.5 1.5 1.5 1.5 1.5 1.5 1.5 1.5 1.5 1.5 1.5 | |||||
| Between-run-CV % | 0.0 - 0.0 0.0 1 3 0.0 5 0.0 5 0.0 0 | ||||||
| 1.2 1412 | 0.0 80.9 8.3 31:31 0.5 0.9 1.0 1.2 | 10.0 10.0 8 2 2 2 1 13 1 10.0 11 12 131 | |||||
| Between-day CV % | 10.5 10.7 10.0 10.70 115 10.3 1.0.6 10.0 | 10.5 10.7 10.73 10.73 11.5 10.3 1.0.6 10.01 | 20.5 10.7 12 3 10.72 1.4 120.4 10.4 10.4 10.4 10.5 | ||||
| Within-device-CV % 11:81 215 11:12 1 31:63 14:0 161:6 1:1.8 151:57 | 19 9 1 1 7 1 8 - 2 1 5 7 7 - 1 6 1 1 . 7 - 1 5 ] | 18 11 8 12 9 12 9 21 8 1 6 1 6 1 6 8 1 6 1 6 8 15 | |||||
| Munich | Local Test System | Prividen Childre ter leit somers 1 | े कि में सेविकारियां दिए ने कहाने | ||||
| Innovin lot 536967 Thromborel S lot 545116 | Innovin lot 536967 Thromborel S lot 545116 | Innovin lot 536967 Thromborel S lot 5451.16 | |||||
| CPP 2C2 NEP PRP CPP C2 NEP PP | CPP RC21 NPF PPP1 CREBICC23 NPR PPP | CRR (C2) NEB PRB CPP (CPP) C23) NPP PPP | |||||
| Mean (INR) | 22313 228 210 183 41 22 5 1 3.7 1 11 13 13 4 | 222 22 3 1 0 1 3 6 1 2 . 4 3 5 5 1 8 1 0 1 3 .3 | 222 229 120 13:61 22:41 3:51 31:0 13:2 | ||||
| Repeatability % | 21.2 10.5 10.5 120.5 120.6 10.9 120.6 | 113 10.6 10.51 10.5 120.5 12.7 10.6 14.12 10.6 | 12.03 10.6 110.2 10.2 13.0 20.8 120.0 | ||||
| Within-day-CV % | 31 8110 71 0 7 10 8 1 5 0 1 4 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 | 119 8078 108 80.8 85.0 84.11 161.5 3:01 | 10.0 20 20.8 10.8 11.4 8 1 4.0 1 4.0 1 1.0 1 1.0 1 | ||||
| Between-run-CV % | 1.31 0.5 10.61 10.61 10.61 13.3 11.4.0 131.41 13.0 | 174112015110.6 120.6 1 40.6 1 4 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 | 12 10 4 10 6 10 6 10 6 1 3 9 1 3 9 1 1 1 1 12 9 | ||||
| Between-day CV % 150:0110.831515131313131313131.0.0: 181.51 2.3. | 10.01 20.81 41.22 121.91 19.0 119.0 1121.58 12.31 | 10.01 10.9 12 152 1511 12.1 10.01 10.00 11 3 1 12:3 | |||||
| Within-device-CV % 18118131312207 5.03112.07 5.0 12413192.11] 13:8, | 19 181241515211 5.0 14.17 22 13.8 | 19 13 13 13 13 12 13 13 13 13 13 13 13 13 7 | |||||
| Previous and Brotant Productions of | Calling of the land of 38585 | ||||||
| Marburg | (oca Test System) | ||||||
| Innovin lot 539126 Thromborel S lot 545248 | Innovin'lot 539126 Thrombore IS lot 545248 | Innovin lot 539126 Thrombore IS lot 545248 | |||||
| CPP C2 Non B BPP CPP C2 NRP PPP | CPP 2C2 NEB PRP CPP CPP CPP RC2 NPP PPG | ICPE ICO21 NRE EPP CERECO NAS I PER | |||||
| Mean (INR) | 222 23.0 110 113.84 227 11:38 141.0 143.3 | 2 41 82 81 81 0 18 61 2 6 2 8 15 15 10 33 16 | 12-21133.0118110 13.71 22.71 23.91 11.01 13.3 | ||||
| 181 07 10 7410 41 14 7 100 51 1039 1037 | |||||||
| Repeatability % | 813 10 61 20 73 10 41 4 7 4 7 1 20 5 10 9 130.7 | 113 120 74 10 74 10 74 20 44 7 2 80 5 2 61 0 1 10 6 8 | |||||
| Within-day-CV % | 21:41 60.8 10.73 2018 11.0 81 8 121.4 1.1.0 121.3 1 | 11.41 10.91 10:72 2019 11.4 88 111 11.0 1 11:38 | |||||
| 10:51 20:74 10:24 18 00 8 1 80 8 1 2 12 1 1 1 1 | 1741 101 20.73 10:00 80.73 10.03 121 11.03 103 11.3 | ||||||
| 10.51 80.78 10.01 10.8 11 131 10.31 10.31 10.32 10.31 | |||||||
| Between-run-CV % | 10:48 10.7 10.0 1 80.88 110 1 11:33 10.5 121 16 | ||||||
| 10.91 813110.67 10.6 17.1 12.3 12.2 10.38 10.3 | 312 13 13 1 1 1 1 12 3 32 2 1 1 0 10 3 3 | 10.8 13 13 10.6 1310 12.3 13.2 2 1510 10.4 | |||||
| Between-day CV % | Within-device-CV % [21:6] 51:67 0.9 ] 81:49 [5.4 1.2.7 ] 11:4 01:3 | 1.7.1. 1. 1.0.99.2.6.2. 1.4.1.5.3.132.8.1.1.4.1.3 | 116 116 10.9 131.41 5.4 152.7 121.4 1813 | ||||
| Sample legend: | CPP Control Plasma P | below lowest calibrator | |||||
| C2 | |||||||
| ICi-Trol 2 | |||||||
| NPP | |||||||
| (normal plasma pool | |||||||
| ppp | |||||||
| pathological plasma pool |
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol on the right side. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Siemens Healthcare Diagnostics Inc. c/o Mr. Radames Riesgo Regulatory Affairs & Compliance Manager Glasgow Business Community (GBC) PO Box 6101 MS 514 Newark, DE 19702
DEC 2 0 2010
Re: K093848
Trade/Device Name: PT-Multi Calibrator Regulation Number: 21 CFR §864.5425 Regulation Name: Multipurpose System for In Vitro Coagulation Studies Regulatory Class: Class II Product Code: GGN, JIS Dated: November 29, 2010 Received: November 30, 2010
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 class II (Special Controls), 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 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
4
Page 2 - Mr. Radames Riesgo
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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address . http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Thara McLen
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
Enclosure
5
Attachment 4
Indications for Use Statement
510(k) Number (if known): K093848
Device Name: PT-Multi Calibrator DEC 2 0 2010
Indications for Use:
Intended Use: PT-Multi Calibrator is intended as a calibrator set for local PT/INR calibration and/or local verification of the INR system for plasma based procedures with designated Siemens thromboplastins Dade® Innovin® or Thromborel® S on the BCS® / BCS® XP Systems.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Page 1 of 1
Office of In Vitro Diagnostic
Device Evaluation and Safety
510(k) K093848