(29 days)
Not Found
No
The document describes a lyophilized control plasma for coagulation tests and does not mention any AI or ML components.
No
This device is a control material for diagnostic tests, specifically for monitoring the precision and accuracy of coagulation and fibrinolysis tests, rather than providing therapy.
No
Explanation: The device is described as an "assayed control" intended to "monitor and evaluate the precision and accuracy of coagulation and fibrinolysis tests." This indicates it is a quality control material for diagnostic tests, not a diagnostic device itself.
No
The device description clearly states it is a lyophilized control prepared from pooled human plasma, which is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it is "assayed for use as an accuracy control of the following parameters in the normal range: Prothrombin time (PT); Activated partial thromboplastin time (aPTT); Thrombin time (TT); Batroxobin time; Fibrinogen; Coagulation factors... Inhibitors... Plasminogen; Total complement activity**, Lupus anticoagulants." These are all tests performed on biological samples (plasma) in vitro (outside the body) to provide information about a patient's health status.
- Device Description: It is described as a "Iyophilized control prepared from pooled human plasma... It is an assayed control intended to monitor and evaluate the precision and accuracy of coagulation and fibrinolysis tests in the normal range." This further confirms its use in the laboratory setting for quality control of diagnostic tests.
- Predicate Device: The mention of a predicate device "Control Plasma N (K00125)" indicates that this type of device has been previously classified and regulated as an IVD by a regulatory body (likely the FDA, given the K number format).
Therefore, based on the intended use, device description, and the reference to a predicate device, this product is clearly an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Control Plasma N is assayed for use as an accuracy control of the following parameters in the normal range:
- Prothrombin time (PT) · 1.
- Activated partial thromboplastin time (aPTT) 2.
- Thrombin time (TT)* 3.
-
- Batroxobin time*
- ട്. Fibrinogen
- Coagulation factors II, V, VII, VIII, VWF, IX, X, XI, and XII ర్.
-
- Inhibitors: Antithrombin III, Protein C, Protein S, az-antiplasmin,
- Plasminogen 8.
- മ. Lupus anticoagulants
- Not for BFT™II analyzer
Product codes
GIZ
Device Description
Control Plasma N is a Iyophilized control prepared from pooled human plasma. stabilized with HEPES buffer solution. It is an assayed control intended to monitor and evaluate the precision and accuracy of coagulation and fibrinolysis tests in the normal range.
Mentions image processing
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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)
Stability: In duplicate determinations, reconstituted stability data met the acceptance criteria of recovering within the assigned values for the following claims: 4 hours at +15 to +25°C; 4 weeks at -20 to -30°C (2 hours after thawing at +15 to +25°C, stored for 4 weeks at -20 to -30°C).
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.
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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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§ 864.5425 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
Dade Behring Inc. Control Plasma N 510(k) Modification
:
·
NOV 1 2002
ATTACHMENT 5
510(k) Summary
1
510(k) Summary Control Plasma N
1. 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.
Glasgow Site
P.O. Box 6101
Newark, Delaware 19714
Attn: Donna Wolf
Tel: 302-631-0384 |
| Preparation date: | October 2, 2002 |
2. Device Name/ Classification:
Control Plasma N / Multipurpose system for in vitro coagulation studies, Class II (864.5425)
3. Identification of the Legally Marketed Device:
Control Plasma N (K00125)
4. Device Description:
Control Plasma N is a Iyophilized control prepared from pooled human plasma. stabilized with HEPES buffer solution. It is an assayed control intended to monitor and evaluate the precision and accuracy of coagulation and fibrinolysis tests in the normal range.
5. Device Intended Use:
Control Plasma N is assayed for use as an accuracy control for use 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, VWfF IX, X, XI, XII and XIII ; Inhibitors: Antithrombin III, Protein C, Protein S, as -antiplasmin, C, inhibitor: Plasminogen; Total complement activity**, Lupus anticoagulants. (* Not for BFT ™II analyzer, ** Not available in the U.S.)
6. Medical device to which equivalence is claimed and comparison information:
Control Plasma N (modified) is substantially equivalent in intended use to the Control Plasma N (K001256) currently marketed. Control Plasma N (modified). like the current Control Plasma N is intended for use as an assayed quality control material to monitor the accuracy and precision of various coagulation and fibrinolysis tests in the normal range using a variety of mechanical and photooptical coaqulation systems.
7. Device Performance Characteristics: Stability:
In duplicate determinations, reconstituted stability data met the acceptance criteria of recovering within the assigned values for the following claims: 4 hours at +15 to +25°C; 4 weeks at -20 to -30°C (2 hours after thawing at +15 to +25°C, stored for 4 weeks at -20 to -30°C).
2
Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is centered in the image. The font is a serif font, and the text is black. The background is white.
od and Drug Administra 98 Gaither Road ockville MD 20850
Ms. Donna A. Wolf Senior Regulatory Affairs Specialist Dade Behring Inc. P.O. Box 6101 Newark, DE 19714
K023309 Re: Trade/Device Name: Control Plasma N Regulation Number: 21 CFR 864.5425 Regulation Name: Multipurpose System for In Vitro Coagulation Studies Regulatory Class: Class II Product Code: GIZ Dated: October 2, 2002 Received: October 3, 2002
Dear Ms. Wolf:
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 -
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 1 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Steven Butman
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
4
Control Plasma N. K023309 Control Plasma P. K023312 Response to Questions
Indications for Use Statement
Device Name:
Control Plasma N
.
Indications for Use:
Control Plasma N is assayed for use as an accuracy control of the following parameters in the normal range:
- Prothrombin time (PT) · 1.
- Activated partial thromboplastin time (aPTT) 2.
- Thrombin time (TT)* 3.
-
- Batroxobin time*
- ട്. Fibrinogen
- Coagulation factors II, V, VII, VIII, VWF, IX, X, XI, and XII ర్.
-
- Inhibitors: Antithrombin III, Protein C, Protein S, az-antiplasmin,
- Plasminogen 8.
- മ. Lupus anticoagulants
- Not for BFT™II analyzer
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
EDRH, Office of Device Evaluation (ODE) rence · 11 11
(Division)Sian-Off Division of Clinical Laboratory Devices
510(k) Number K 023309
Prescription Use v (Per 21 CFR 801.109)
Over-The-Counter-Use (Optional Format 1-2-96)