(105 days)
The Boehringer Mannheim Precinorm® TDM Controls are used to monitor accuracy and precision.
Precinorm® TDM is a triple range lyophilised control material based on human serum.
Precinorm® TDM is used for monitoring accuracy or precision.
The Boehringer Mannheim Precinorm® TDM Controls are manufactured using human serum albumin, therapeutic drugs, stabilizers, and preservatives. The analytes are appropriately spiked into the control matrix to the correct control concentration levels. The controls are in process checked, and a value assignment process is done via a comparison to an analyte specific (and chemistry specific) calibrator.
The Boehringer Mannheim Precinorm® TDM Controls are quality control materials used to monitor the accuracy and precision of therapeutic drug monitoring (TDM) assays. The study aims to demonstrate substantial equivalence to a predicate device, the Baxter Dade® IAC-X Comprehensive Immunoassay Control (K912455).
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly define quantitative "acceptance criteria" in a typical numerical format (e.g., specific accuracy percentages, precision coefficients of variation). Instead, the performance assessment relies on demonstrating "equivalent performance to the predicate device" in terms of dose assignment and stability.
| Acceptance Criteria Category | Reported Device Performance (Precinorm® TDM Controls) | Equivalence to Predicate? |
|---|---|---|
| Dose Assignment | Equivalent to the predicate device. | Yes |
| Stability | Equivalent to the predicate device. | Yes |
| Intended Use | Similar intended use (monitor accuracy and precision). | Yes |
| Matrix | Similar matrix (human serum albumin base). | Yes |
| Stability Claims | Similar stability claims. | Yes |
| Control Levels | Tri-level (similar to predicate). | Yes |
Note: The document states, "Specific data on the performance of the controls have been incorporated into the draft labeling in attachment 5." However, this attachment is not provided in the input, so quantitative performance metrics for dose assignment and stability are not extractable here. The claim of "equivalent performance" is the reported result.
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the sample size used for the test set or provide details on the data provenance (e.g., country of origin, retrospective or prospective) for the performance characteristics. The focus of the provided text is on the substantial equivalence argument, rather than a detailed breakdown of a specific clinical study for the device's performance. The "performance characteristics" section is very brief, simply stating equivalence without presenting raw data or study design.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the document. As this device is a quality control material rather than a diagnostic device for patient samples, the concept of "ground truth" established by experts in the context of clinical reads (like radiologists) is not directly applicable. The "ground truth" for a control material would typically be its assigned value, which is determined through a value assignment process, often involving reference methods or comparison to established calibrators.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided. Adjudication methods (like 2+1, 3+1 consensus) are typically used in studies where human readers are interpreting images or clinical data, which is not the nature of evaluating a quality control material.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This information is not applicable and therefore not provided. This device is a quality control material and does not involve AI or human reader interpretation of diagnostic cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable and therefore not provided. The device is a quality control material, not an algorithm, and the concept of "standalone performance" in this context is not relevant.
7. The Type of Ground Truth Used
For a quality control material like the Precinorm® TDM Controls, the "ground truth" is generally established through a value assignment process. The document states:
- "a value assignment process is done via a comparison to an analyte specific (and chemistry specific) calibrator."
This implies that the ground truth for the assigned values of the controls is based on established, highly characterized calibrators and potentially reference measurement procedures, ensuring traceability and accuracy.
8. The Sample Size for the Training Set
This information is not provided and is likely not applicable in the traditional sense of a "training set" for an AI algorithm. This device is a manufactured chemical control, not a machine learning model. The manufacturing process and value assignment would involve rigorous quality control and validation, but not a "training set" in the computational context.
9. How the Ground Truth for the Training Set Was Established
As noted above, the concept of a "training set" is not relevant here. The ground truth for the assigned values of the control material is established through a value assignment process involving comparison to analyte-specific and chemistry-specific calibrators. This process ensures that the reported concentrations for each analyte in the control are accurate and traceable.
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JUL - 7 1997
| BOEHRINGERMANNHEIMCORPORATION | Image: boehringer mannheim logo | |
|---|---|---|
| Summary | ||
| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. | |
| 1.Submittername,address,contact | Boehringer Mannheim Corporation2400 Bisso LaneConcord, CA 94524-4117(510) 674-0690 extension 8413Fax number: (510) 687-1850Contact Person: Yvette LloydDate Prepared: March 20, 1997 | |
| 2.Device Name | Proprietary name: Precinorm® TDM ControlsCommon name: ControlsClassification name: Single (specified) analyte controls (assayed + unassayed) | |
| 3.Predicatedevice | The Boehringer Mannheim Precinorm® TDM Controls are substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the Baxter Dade® IAC-X Comprehensive Immunoassay Control (K912455). | |
| 4.DeviceDescription | The Boehringer Mannheim Precinorm® TDM Controls are manufactured using human serum albumin, therapeutic drugs, stabilizers, and preservatives. The analytes are appropriately spiked into the control matrix to the correct control concentration levels. The controls are in process checked, and a value assignment process is done via a comparison to an analyte specific (and chemistry specific) calibrator. |
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| Summary, Continued | |
|---|---|
| -- | -------------------- |
| 5. Intended use | The Boehringer Mannheim Precinorm® TDM Controls are used to monitor accuracy and precision. |
|---|---|
| 6. Comparison to predicate device | The Boehringer Mannheim Precinorm® TDM Controls are substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the Baxter Dade® IAC-X Comprehensive Immunoassay Control (K912455). |
The following table compares the Boehringer Mannheim Precinorm® TDM Controls with the predicate device, the Baxter Dade® IAC-X Comprehensive Immunoassay Controls. Specific data on the performance of the controls have been incorporated into the draft labeling in attachment 5. Labeling for the predicate devices are provided in attachment 6..
Similarities:
-
Similar intended use
-
Similar matrix
-
Similar stability claims
-
Both are tri-level
:
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510(k) Summary, Continued
1
Differences:
| Feature | Precinorm® TDM Control | Baxter-Dade® Immunoassay Control |
|---|---|---|
| Analytes | T4, T-Uptake, T3, Amikacin,Carbamazepine, Hydrocortisone(Cortisol), Quinidine, Digoxin,Digitoxin, Disopyramide,Ethosuximide, Gentamicin, Lidocaine,Phenobarbital, Phenytoin, Primidone,Procainamide, N-acetylprocainamide,Theophylline, Tobramycin, ValproicAcid, Methotrexate, Chloramphenicol,Salicylic Acid, Lithium,Acetaminophen, Propanolol,Vancomycin, and Streptomycin. | Acetaminophen, Alpha-Fetoprotein(AFP), Aldosterone, Amikacin,Carbamazepine, CarcinoembryonicAntigen (CEA), Cortisol,Cyclosporine, Digoxin, Disopyramide,Estradiol, Ethosuximide, Ferritin,Folate, Free T3, Free T4, FollicleStimulating Hormone (FSH),Gentamicin, Human ChorionicGonadotropin, (hCG), Human GrowthHormone (hGH), Human LuteinizingHormone (hLH), Immunoglobulin E(IgE), Insulin, Iron Binding Capacity,Lidocaine, Lithium, N-acetylprocainamide (NAPA), ProstaticAcid Phosphatase (PAP),Phenobarbital, Phenytoin, Primidone,Procainamide, Progesterone, Prolactin,Prostate Specific Antigen (PSA),Parathyroid Hormone (PTH),Quinidine, Salicylate, Serum Iron,Tricyclic Antidepressants (TCA),Testosterone, Theophylline, ThyroidUptake/T3 Uptake,Tobramycin, Total T3, Total T4, TSH,Valproic Acid, Vancomycin, VitaminB12 |
| ReconstitutionInstructions | Add 3 mL of distilled water, then letsit for 30 minutes, with occasionalswirling. | Add 5 mL of distilled or deionizedwater, then let stand at roomtemperature for 10 minutes. |
Continued on next page
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Summary, Continued
Image /page/3/Picture/1 description: The image is a logo for Boehringer Mannheim. The logo is a black square with a white circle in the center. The word "boehringer" is written in white letters inside the circle. The word "mannheim" is written vertically in white letters on the left side of the square.
- Comparison to predicate
device, (cont.)
Performance Characteristics:
· Dose assignment and stability: equivalent performance to the predicate device.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Yvette R. Lloyd Requlatory Affairs Specialist Boehringer Mannheim Corporation ...... 2400 Bisso Lane P.O. Box 4117 94524-4117 Concord, California
K971060 Re : Precinorm™ TDM Controls Requlatory Class: I Product Code: DIF June 20, 1997 Dated: Received: June 23, 1997 JUL - 7 1997
Dear Ms. Lloyd:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
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 requlation (21 CFR Part 801 and 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Litman
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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ications For Use:
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人民网 上海
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minorm® TDM is a triple range lyophilised control material based on human serum.
monorm® TDM is used for monitoring accuracy or precision.
acinorm (R) TDM
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Concurrence of CDRH, Office of Device Evaluation (ODE)
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Over-The-Counter Use
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§ 862.3280 Clinical toxicology control material.
(a)
Identification. A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.