(29 days)
Control Plasma N 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 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.)
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.
The provided text describes a 510(k) modification for "Dade Behring Inc. Control Plasma N." This product is a control plasma used to monitor the precision and accuracy of coagulation and fibrinolysis tests. The study described focuses on the stability of the control plasma.
Here's an analysis of the provided information, structured according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Reconstituted stability data must recover within the assigned values for the claims. | The reconstituted stability data met the acceptance criteria of recovering within the assigned values for the following claims: |
| Specific Claims: | |
| 4 hours at +15 to +25°C | Met (recovered within assigned values) |
| 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) | Met (recovered within assigned values) |
2. Sample Size Used for the Test Set and Data Provenance
The document states, "In duplicate determinations, reconstituted stability data met the acceptance criteria..." This indicates that the test for stability was performed in duplicate, meaning each stability condition was tested twice.
- Sample Size: "Duplicate determinations" (implies n=2 for each condition tested).
- Data Provenance: The document does not specify the country of origin of the data. Given the manufacturer is Dade Behring Marburg GmbH (Germany) and the contact is Dade Behring Inc. (USA), the testing could have occurred in either location or a combination. The study is prospective as it's testing the stability of the device under defined conditions.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of study (stability testing of a control plasma) does not typically involve human experts establishing a "ground truth" in the same way as, for example, a diagnostic imaging study. The "ground truth" here is the assigned values of the control plasma, which are determined through standardized assays and extensive validation by the manufacturer, likely involving laboratory scientists and statisticians. The document does not provide details on this process or the number/qualifications of individuals involved in establishing these assigned values.
4. Adjudication Method for the Test Set
Not applicable. As this is a quantitative analytical measurement (recovery within assigned values), there is no "adjudication method" in the sense of expert review or consensus. The results are compared directly against predefined acceptance limits.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This is a stability study for a laboratory control, not a diagnostic device involving human interpretation of cases. Therefore, an MRMC comparative effectiveness study is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a sense. The "device" (Control Plasma N) itself is a chemical reagent. Its performance is evaluated through laboratory assays. The "standalone" performance here refers to the Control Plasma N maintaining its intended characteristics (i.e., its concentrations/activity of various analytes) over time under specified storage conditions, as measured by standard laboratory tests. There is no "algorithm" in the context of image analysis or AI, but the performance is measured purely instrumentally/analytically without human intervention influencing the concentration results.
7. The Type of Ground Truth Used
The ground truth used here is the assigned values for each parameter (e.g., PT, aPTT, Fibrinogen, etc.) in the Control Plasma N. These assigned values are established by the manufacturer through rigorous testing using reference methods and/or calibrated instruments to determine the expected concentration or activity of each analyte within the control. The stability test then verifies if the values obtained after storage remain within acceptable limits of these assigned ground truth values.
8. The Sample Size for the Training Set
Not applicable. This is a stability study for a control plasma, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set. The "assigned values" for the control material (which serves as the "ground truth" for the stability study) are established by the manufacturer through extensive characterization and validation of the product, typically involving multiple lots and rigorous measurement protocols, prior to its use as a control in other assays. The document doesn't detail this process for the assigned values themselves, only their use in the stability test.
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Dade Behring Inc. Control Plasma N 510(k) Modification
:
·
NOV 1 2002
ATTACHMENT 5
510(k) Summary
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510(k) Summary Control Plasma N
1. Manufacturer's Name, Address, Telephone, and Contact Person, Date of Preparation:
| Manufacturer: | Dade Behring Marburg GmbHEmil-von-Behring Str. 76Marburg/Germany |
|---|---|
| Contact Information: | Dade Behring Inc.Glasgow SiteP.O. Box 6101Newark, Delaware 19714Attn: Donna WolfTel: 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).
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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.
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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
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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)
§ 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.