(105 days)
Not Found
No
The summary describes a quality control material for therapeutic drug monitoring, not a device that processes data or images using AI/ML.
No.
The device is a control used to monitor the accuracy and precision of therapeutic drug monitoring (TDM) assays, not to provide therapy itself.
No.
The device is a control used to monitor the accuracy and precision of immunoassay tests, not to diagnose a condition itself. It is used as a quality control for other devices.
No
The device description explicitly states it is manufactured using physical components (human serum albumin, therapeutic drugs, stabilizers, and preservatives) and is a control material, not software.
Based on the provided information, the Boehringer Mannheim Precinorm® TDM Controls are likely an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "to monitor accuracy and precision." This is a common function of control materials used in laboratory testing to ensure the reliability of diagnostic assays.
- Device Description: The description mentions the controls are manufactured using human serum albumin and therapeutic drugs, and are used in a "value assignment process via a comparison to an analyte specific (and chemistry specific) calibrator." This strongly suggests they are used in the context of in vitro diagnostic testing.
- Predicate Device: The predicate device listed, K912455; Baxter Dade® IAC-X Comprehensive Immunoassay Control, is also a control material used in immunoassay testing, which is a type of in vitro diagnostic procedure.
While the document doesn't explicitly state "In Vitro Diagnostic," the context of its use in monitoring accuracy and precision of therapeutic drug monitoring (TDM) and its comparison to a calibrator, along with the nature of the predicate device, all point towards it being an IVD. Control materials are essential components of quality control in IVD testing.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DIF
Device Description
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.
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)
Performance Characteristics:
· Dose assignment and stability: equivalent performance to the predicate device.
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
§ 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.
0
Image /page/0/Picture/0 description: The image contains a sequence of digits and a letter, specifically 'K971060'. The characters are handwritten in a bold, somewhat uneven style. A horizontal line is present beneath the sequence, possibly indicating underlining or a boundary.
JUL - 7 1997
| BOEHRINGER
MANNHEIM
| CORPORATION | 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. | ||
| Submitter | ||
| name, | ||
| address, | ||
| contact | Boehringer Mannheim Corporation | |
| 2400 Bisso Lane | ||
| Concord, CA 94524-4117 | ||
| (510) 674-0690 extension 8413 | ||
| Fax number: (510) 687-1850 |
Contact Person: Yvette Lloyd
Date Prepared: March 20, 1997 | |
| 2.
Device Name | Proprietary name: Precinorm® TDM Controls
Common name: Controls
Classification name: Single (specified) analyte controls (assayed + unassayed) | |
| 3.
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). | |
| 4.
Device
Description | 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. | |
1
| 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
:
2
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, Valproic | ||
| Acid, Methotrexate, Chloramphenicol, | ||
| Salicylic Acid, Lithium, | ||
| Acetaminophen, Propanolol, | ||
| Vancomycin, and Streptomycin. | Acetaminophen, Alpha-Fetoprotein | |
| (AFP), Aldosterone, Amikacin, | ||
| Carbamazepine, Carcinoembryonic | ||
| Antigen (CEA), Cortisol, | ||
| Cyclosporine, Digoxin, Disopyramide, | ||
| Estradiol, Ethosuximide, Ferritin, | ||
| Folate, Free T3, Free T4, Follicle | ||
| Stimulating Hormone (FSH), | ||
| Gentamicin, Human Chorionic | ||
| Gonadotropin, (hCG), Human Growth | ||
| Hormone (hGH), Human Luteinizing | ||
| Hormone (hLH), Immunoglobulin E | ||
| (IgE), Insulin, Iron Binding Capacity, | ||
| Lidocaine, Lithium, N- | ||
| acetylprocainamide (NAPA), Prostatic | ||
| Acid Phosphatase (PAP), | ||
| Phenobarbital, Phenytoin, Primidone, | ||
| Procainamide, Progesterone, Prolactin, | ||
| Prostate Specific Antigen (PSA), | ||
| Parathyroid Hormone (PTH), | ||
| Quinidine, Salicylate, Serum Iron, | ||
| Tricyclic Antidepressants (TCA), | ||
| Testosterone, Theophylline, Thyroid | ||
| Uptake/T3 Uptake, | ||
| Tobramycin, Total T3, Total T4, TSH, | ||
| Valproic Acid, Vancomycin, Vitamin | ||
| B12 | ||
| Reconstitution | ||
| Instructions | Add 3 mL of distilled water, then let | |
| sit for 30 minutes, with occasional | ||
| swirling. | Add 5 mL of distilled or deionized | |
| water, then let stand at room | ||
| temperature for 10 minutes. |
Continued on next page
3
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.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, with flowing lines suggesting movement or flight.
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.
5
Page 2
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
6
ications For Use:
ice Name:_
人民网 上海
.....
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
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division . 11 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 510(k) i Vui ... .
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Over-The-Counter Use
(Optional Format 1-2-96)
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