(56 days)
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No
The document describes a quality control product for laboratory analyzers and does not mention any AI or ML components.
No.
The TDM Control Set is a quality control product used to assay therapeutic drugs, not to treat patients.
No
Explanation: The device is a quality control product used to assay therapeutic drugs and is not used to diagnose a patient's medical condition. It helps ensure the accuracy of diagnostic tests but is not itself a diagnostic device.
No
The device description clearly states it contains liquid controls based on human serum with added therapeutic drugs, preservative, and stabilizer, indicating it is a physical product, not software.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for use as an "assayed quality control product on Roche/Hitachi and COBAS INTEGRA analyzers." These analyzers are used to perform in vitro diagnostic tests on patient samples (serum in this case) to measure the levels of therapeutic drugs. Quality controls are essential components of IVD testing to ensure the accuracy and reliability of the results.
- Device Description: The description details the composition of the control set, which is based on human serum with added therapeutic drugs. This material is designed to mimic patient samples and is used in vitro (outside the body) to assess the performance of the diagnostic tests.
- Predicate Device: The mention of a predicate device with the same name ("TDM Control Set") and a K number (K060429) strongly indicates that this device has gone through the FDA's 510(k) clearance process, which is required for many IVD devices.
While the document doesn't explicitly use the term "In Vitro Diagnostic" in the intended use or description, the function and context clearly align with the definition of an IVD. It's a product used in vitro to control the quality of diagnostic tests performed on patient samples.
N/A
Intended Use / Indications for Use
The TDM Control Set is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the value sheet.
The TDM Control Set is intended for use as an assayed quality control product on Roche/Hitachi and COBAS INTEGRA analyzers. Two assayed levels of serum barbiturates and three assayed levels of acetaminophen, amikacin, carbamazepine, digoxin, gentamicin, lidocaine, N-acety/procainamide, phenobarbital, phenytoin, primidone, procainamide, quinidine, salicylate, theophylline, tobramycin, valproic acid and vancomycin are provided.
Product codes (comma separated list FDA assigned to the subject device)
JJY
Device Description
The TDM Control Set contains liquid controls based on human serum with added therapeutic drugs, preservative, and stabilizer. The adjusted concentrations and activities of the control components are usually in the normal range or at the normal/pathological threshold. Some of the methods as specified in the enclosed value sheet may not be available in all countries.
The TDM Control Set contains a mixture of 17 different drugs. Drugs included are acetaminophen, amikacin, carbamazepine, digoxin, gentamicin, lidocaine, N-acetylprocainamide, phenobarbital, phenytoin, primidone, procainamide, quinidine, salicylate, theophylline, tobramycin, valproic acid and vancomycin
The concentrations and activities of the components are lot-specific.
The exact values are given in the enclosed value sheet.
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)
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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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§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
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| 510(k) Summary | MAR 19 2007 |
|---|---|
| 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) Submitter name, address, contact | Roche Diagnostics Corporation |
| 9115 Hague Rd. | |
| Indianapolis, IN 46250 | |
| (317) 521-7688 | |
| Contact Person: Dimitris Demirtzoglou | |
| Date Prepared: January 19, 2007 | |
| 2) Device name | Proprietary name: TDM Control Set |
| Common name: Quality control material (assayed and unassayed). | |
| Classification name: Multi-analyte controls, all kinds (assayed and unassayed) | |
| 3) Predicate devices | We claim substantial equivalence to the currently marketed TDM Control Set (K060429). |
| 4) Device Description | The TDM Control Set contains liquid controls based on human serum with added therapeutic drugs, preservative, and stabilizer. The adjusted concentrations and activities of the control components are usually in the normal range or at the normal/pathological threshold. Some of the methods as specified in the enclosed value sheet may not be available in all countries. |
| The TDM Control Set contains a mixture of 17 different drugs. Drugs included are acetaminophen, amikacin, carbamazepine, digoxin, gentamicin, lidocaine, N-acetylprocainamide, phenobarbital, phenytoin, primidone, procainamide, quinidine, salicylate, theophylline, tobramycin, valproic acid and vancomycin | |
| The concentrations and activities of the components are lot-specific. | |
| The exact values are given in the enclosed value sheet. |
.
Continued on next page
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510(k) Summary, Continued ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| 5.) Intended
Use | The TDM Control Set is for use in quality control by monitoring accuracy and
precision for the quantitative methods as specified in the value sheet. |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 6.) Comparison
to the Predicate
Device | Below the similarities and differences between the modified TDM Control
Set and its predicate device [TDM Control Set (K060429)] are presented. The
device will continue to be sold under the same name, TDM Control Set. |
| | The TDM Control Set contains liquid controls based on human serum with
added therapeutic drugs, preservative, and stabilizer. The TDM Control Set
contains a mixture of 17 different drugs. Drugs included are acetaminophen,
amikacin, carbamazepine, digoxin, gentamicin, lidocaine, N-acetylprocainamide, phenobarbital, phenytoin, primidone, procainamide,
quinidine, salicylate, theophylline, tobramycin, valproic acid
and
vancomycin.
The control set contains three levels for each drug. In addition, the TDM
Control Set is value assigned for two levels (level I & II) of serum
barbiturates, utilizing phenobarbital already present in the controls. |
| | The predicate device, TDM Control Set (K060429) is identical with the
current TDM Control set except that it is not value assigned fo two levels of
serum barbiturates. |
| | No new analytes were added, and no drug levels have changed. Therefore,
stability and composition have not changed. The package insert and intended
use have not changed, but the value assignment for serum barbiturates was
added to the value sheet. The traceability of the controls has not changed,
except of course for the serum barbiturates assignment. |
| | Here is a summary of the TDM Control Set in relation to serum barbiturates: |
| | The TDM Control Set contains phenobarbital. The controls were tested using
the Serum Barbiturates assay. The Serum Barbiturates assay is calibrated
with secobarbital, with cross-reactivity to phenobarbital of approximately
26%. Essentially, we are using the cross-reactivity of the phenobarbital in the
controls to allow us to assign targets for the Serum Barbiturates assay. |
:
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with its wings spread, rendered in black. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle, also in black. The text is in all capital letters.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Roche Diagnostics Corp. 9115 Hague Road, PO Box 50416 Indianapolis, IN 46250-0457 ATTN: Mr. Dimitris Demirtzoglou MAR 1 9 2007
Re: K070200 Trade/Device Name: TDM Control Set Regulation Number: 21 CFR $862.1660 Regulation Name: Quality control material (assayed and unassayed). Regulatory Class: Class I (reserved) Product Code: JJY Dated: March 06, 2007 Received: March 07, 2007
Dear Mr. Demirtzoglou:
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).
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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.
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 (240) 276-0490. 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean m. Cooper, M.S., D.V.M.
Yean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: TDM Control Set
Indications For Use:
The TDM Control Set is intended for use as an assayed quality control product on Roche/Hitachi and COBAS INTEGRA analyzers. Two assayed levels of serum barbiturates and three assayed levels of acetaminophen, amikacin, carbamazepine, digoxin, gentamicin, lidocaine, N-acety/procainamide, phenobarbital, phenytoin, primidone, procainamide, quinidine, salicylate, theophylline, tobramycin, valproic acid and vancomycin are provided.
Prescription Use x (Part 21 CFR 801 Subpart D)
5100
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(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
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