(93 days)
Not Found
No
The device is a control plasma used for monitoring the performance of coagulation assays. The description focuses on its composition and stability, with no mention of AI or ML.
No
This device is described as an assayed control for monitoring the performance of various coagulation parameters, not for treating any condition or disease.
No
This device is a control plasma, which is used to monitor the performance of assays. It does not diagnose medical conditions itself.
No
The device description explicitly states it is a lyophilized control prepared from pooled human plasma, indicating it is a physical substance, not software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is "for use in monitoring performance of the following parameters..." These parameters are all related to analyzing biological samples (plasma) to assess various aspects of the coagulation system. This is a core function of IVD devices.
- Device Description: The device is prepared from pooled human plasma, which is a biological sample used in in vitro testing.
- Predicate Devices: The mention of predicate devices with K numbers (K023309 and K963111) strongly indicates that this device has gone through a regulatory process, likely with the FDA, which is required for IVD devices in the US. The names of the predicate devices also include "Control Plasma," further supporting its IVD nature.
The fact that it's a "control" plasma is also characteristic of IVD devices. Controls are used to verify the accuracy and performance of diagnostic tests.
N/A
Intended Use / Indications for Use
Control Plasma N is an assayed control for use in monitoring the performance of the following parameters in the normal range:
-
- Prothrombin time (PT)
-
- Activated partial thromboplastin time (APTT)
-
- Thrombin time (TT)
-
- Batroxobin time
-
- Fibrinogen
-
- Coagulation factors II, V, VII, VIII, VWF, IX, X, XI, XII
-
- Inhibitors: Antithrombin III, protein C, protein S, a2 -antiplasmin
-
- Plasminogen
-
- Lupus anticoagulants
-
- Factor V Leiden
ProC® Control Plasma is an assayed control used to monitor the performance of Factor V Leiden assay in the pathological range.
Product codes (comma separated list FDA assigned to the subject device)
GGN
Device Description
Control Plasma N is a lyophilized control prepared from pooled human plasma, stabilized with HEPES buffer solution. ProC® Control Plasma is a lyophilized control prepared from pooled human plasma and rabbit plasma, and stabilized with HEPES buffer solution.
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)
Reconstituted stability data of Control Plasma N and ProC® Control Plasma met the acceptance criteria of recovering within the assigned values for the following claims: 4 hours at 15 to 25°; 4 weeks at -20°C or below.
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
DEC - 1 2004
510(k) Summary Control Plasma N and ProC® Control Plasma Manufacturer's Name, Address, Telephone, and Contact Person, Date of
- Preparation:
| Manufacturer: | Dade Behring Marburg GmbH
Emil-von-Behring Str. 76
Marburg/Germany |
|----------------------|--------------------------------------------------------------------------|
| Contact Information: | Dade Behring Inc |
Contact Information:
Dade Behring Inc. Glasgow Site P.O. Box 6101
Newark, Delaware 19714 Attn: Radames Riesgo Tel: 305.480.7558
August 27, 2004 Preparation date:
Device Name/ Classification: 2.
Control Plasma N and ProC® Control Plasma / Multipurpose system for in vitro coagulation studies, Class II (864.5425)
ldentification of the Legally Marketed Device: 3.
Control Plasma N (K023309) and Chromogenix Control Plasma Level 2 (K963111)
4. Device Description:
Control Plasma N is a lyophilized control prepared from pooled human plasma, stabilized with HEPES buffer solution. ProC® Control Plasma is a lyophilized control prepared from pooled human plasma and rabbit plasma, and stabilized with HEPES buffer solution.
Device Intended Use: 5.
Control Plasma N is an assayed control for use in monitoring the performance of the following parameters in the normal range:
-
- Prothrombin time (PT)
-
- Activated partial thromboplastin time (APTT)
-
- Thrombin time (TT)
-
- Batroxobin time
-
- Fibrinogen
-
- Coagulation factors II, V, VII, VIII, VWF, IX, X, XI, XII
-
- Inhibitors: Antithrombin III, protein C, protein S, a2 -antiplasmin
-
- Plasminogen
-
- Lupus anticoagulants
-
- Factor V Leiden
ProC® Control Plasma is an assayed control used to monitor the performance of Factor V Leiden assay in the pathological range.
1
Medical device to which equivalence is claimed and comparison 6. information:
Control Plasma N (modified) is substantially equivalent in intended use to Control Plasma N (K023309) and ProC® Control Plasma is substantially equivalent in intended use to Chromogenix Control Plasma Level 2 (K963111).
Device Performance Characteristics: 7.
Reconstituted stability data of Control Plasma N and ProC® Control Plasma met the acceptance criteria of recovering within the assigned values for the following claims: 4 hours at 15 to 25°; 4 weeks at -20°C or below.
2
Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of a stylized bird.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Radames Riesgo Manager, Regulatory Affairs and Compliance Dade Behring, Inc. Glasgow Site P.O. Box 6101 Newark, Delaware 19714
DEC - 1 2004
Re: K042333
Trade/Device Name: Control Plasma N and ProC® Control Plasma Regulation Number: 21 CFR § 864.5425 Regulation Name: Multipurpose system for in vitro coagulation studies Regulatory Class: II Product Code: GGN Dated: November 3, 2004 Received: November 4, 2004
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); 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.
3
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,
Robert L. Becker, Jr.
Robert L. Becker, Jr., M.D., Ph. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known):
Control Plasma N Device Name:
Indications for Use:
Control Plasma N is an assayed control for use in monitoring performance of the following parameters in the normal range:
-
- Prothrombin time (PT)
-
- Activated partial thromboplastin time (APTT)
-
- Thrombin time (TT)
-
- Batroxobin time
-
- Fibrinogen
-
- Coagulation factors II, V, VII, VIII, VWF, IX, X, XI, XII
-
- Inhibitors: Antithrombin III, protein C, protein S, α2 –antiplasmin
-
- Plasminogen
-
- Lupus anticoagulants
-
- Factor V Leiden
| 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
Office of In Vitro Diagnostic Device Evaluation and Safety
| 510(k) | K042333 |
|---|---|
| -------- | --------- |
Page 1 of 1
Page 29 of 35
5
Indications for Use Statement
510(k) Number (if known): K042333
ProC® Control Plasma Device Name:
Indications for Use:
ProC® Control Plasma is an assayed control used to monitor the performance of Factor V Leiden assay in the pathological range.
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)
Josephine Bautista
Division Sign-Off
Page 1 of 1
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K042333