(28 days)
Not Found
No
The summary describes a quality control material for a laboratory assay, not a device that processes data or images using AI/ML.
No
The device is a quality control product for an assay, not for direct diagnosis or treatment.
No
Explanation: The device is described as "Myoglobin Controls" used for the quality control of an assay, implying it is a control material for verifying the accuracy and precision of a test, not performing a diagnostic test itself.
No
The device description clearly states it is manufactured using physical components (human serum albumin, myoglobin, stabilizers) and is a control material for a laboratory assay, not a software application.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the controls are used for the "quality control of the Boehringer Mannheim Tinaquant Myoglobin assay" and for "monitoring accuracy and precision" of this assay. This indicates that the controls are used in vitro (outside the body) to evaluate the performance of a diagnostic test.
- Device Description: The description details the composition of the controls (human serum albumin, myoglobin, stabilizers) and how they are manufactured and value assigned. This aligns with the nature of IVD control materials.
- Predicate Device: The mention of a predicate device (K902154 Behring N Latex Myoglobin assay) further supports the IVD classification. Predicate devices are typically other legally marketed IVDs that a new device is compared to for regulatory purposes.
The fact that it's a control material for an assay, rather than the assay itself, doesn't change its IVD status. Control materials are essential components of many IVD systems, used to ensure the reliability and accuracy of the diagnostic results.
N/A
Intended Use / Indications for Use
The Boehringer Mannheim Myoglobin Controls are used for the quality control of the Boehringer Mannheim Tinaquant Myoglobin assay.
The Myoglobin Control Set are used for monitoring accuracy and precision of the Boehringer Mannheim Tinaquant Myoglobin assay.
Product codes (comma separated list FDA assigned to the subject device)
JJX
Device Description
The Boehringer Mannheim Myoglobin Controls are manufactured using human serum albumin. Myoglobin, and stabilizers. The analyte is 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
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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)
Not Found
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
§ 862.1660 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.
0
--> FDA DCLD
K97335
@003
OCT - 6 1997
510(k) Summary
According to the requirements of 21 CFR 807.92, the following information Introduction provides sufficient detail to understand the basis for a determination of substantial equivalence. Boehringer Mannheim Corporation 1. Submitter 2400 Bisso Lane name. Concord, CA 94524-4117 address. (510) 674-0690 extension 8413 contact Fax number: (510) 687-1850 Contact Person: Yvette Lloyd Date Prepared: September 30, 1997 Proprietary name: Myoglobin Control Set 2. Device Name Common name: Controls Classification name: Single (specified) analyte controls (assayed + unassayed) The Boehringer Mannheim Myoglobin Control Set is a new product. 3. Predicate device The Boehringer Mannheim Myoglobin Control Set is substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the myoglobin controls contained in the Behring N Latex Myoglobin assay (K902154). The Boehringer Mannheim Myoglobin Controls are manufactured using 4. Device human serum albumin. Myoglobin, and stabilizers. The analyte is Description 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. Continued on next page
--page 24
1
510(k) Summary, Continued
| 5.
| Intended use | The Boehringer Mannheim Myoglobin Controls are used for the quality control of the Boehringer Mannheim Tinaquant Myoglobin assay. |
|---|---|
| 6. | |
| Comparison | |
| to predicate | |
| device | The Boehringer Mannheim Myoglobin Control Set is substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the myoglobin controls contained in the Behring N Latex Myoglobin assay (K902154). |
The following table compares the Boehringer Mannheim Myoglobin Control Set with the predicate device, the Behring Myoglobin Control. 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
Continued on next page
ﺮ ﺍﻟ
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes representing the three branches of government. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
OCT = 6 1997
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Yvette Lloyd . Regulatory Affairs Specialist Boehringer Mannheim Corporation 2400 Bisso Lane P.O. Box 4117 Concord, California 94524-4117
K973358 Re : Myoglobin Control Set Requlatory Class: I Product Code: JJX September 4, 1997 Dated: Received: September 8, 1997
Dear Ms. Lloyd:
requlations.
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, Druq, and Cosmetic Act (Act). 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 (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 requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (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
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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 regulation (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 qeneral 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
4
510(k) Number (if known): N/A
Device Name: Myoglobin Control Set
Indications For Use:
器 元 111
The Myoglobin Control Set are used for monitoring accuracy and precision of the Boehringer Mannheim Tinaquant Myoglobin assay.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
(Div:
Divi
510(k) N
K973358