(71 days)
Not Found
No
The summary describes a control material for glucose analyzers and does not mention any AI or ML components.
No.
This device is a control used to measure the linearity of glucose analyzers, not to directly treat a patient's condition.
No
Explanation: The device is a control used to measure the linearity of glucose analyzers, not to diagnose a patient's condition. It's used for quality control of other diagnostic devices.
No
The device description clearly states it is a "multilevel control" used for measuring linearity of glucose analyzers. This indicates a physical control material, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that it is a "multilevel control that provides a means of measuring the linearity of glucose analyzers for glucose parameter determinations." This indicates that the device is used in vitro (outside the body) to assess the performance of another diagnostic device (glucose analyzers).
- Device Description: The description reinforces the intended use, stating it's a control for measuring the linearity of glucose analyzers.
- Predicate Device: The mention of a predicate device (K993321 R&D Systems Glucose Hemoglobin Hematology Control) which is also a control for hematology analyzers, further supports its classification as an IVD. Controls are a common type of IVD used to verify the accuracy and performance of diagnostic tests.
Therefore, based on the provided information, the R&D GLU-LINE Hematology Control fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
R&D GLU-LINE Hematology Control is designed as a multilevel control that provides a means of measuring the linearity of glucose analyzers for the glucose parameter.
R&D GLU-LINE Hematology Control is a multilevel control that provides a means of measuring the linearity of glucose analyzers for glucose parameter determinations.
Product codes (comma separated list FDA assigned to the subject device)
JJX
Device Description
This control is a multilevel control that provides a means of measuring the linearity of glucose analyzers for the glucose parameter.
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)
Laboratory testing of 3 validation lots has shown R&D GLU-LINE Hematology Control to have substantial equavalence in performance, precision and stability to the predicate device. R&D GLU-LINE Hematology Control passed the acceptance criteria of remaining within the assay range over the life of the product. R&D GLU-DINE Hematology Control has demonstrated precision as indicated by the small standard deviation obtained during laboratory testing. Expiriation dating has been established at 105 days (closed vial) when stored at 2 - 8° C and handled according to instructons for use.
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
510(k) Summary R&D Systems, Inc. GLU-LINE Hematology Control
| Date of Summary: | December 16, 2003 |
|---|---|
| Company Name: | R&D Systems, Inc. |
| 614 McKinley Place N.E. | |
| Minneapolis, MN 55413 | |
| Contact name: | Ralph E. Hogancamp |
| 612-656-4413, FAX 612-379-6809 | |
| Classification name: | Hematology Quality Control Mixture |
| Product name: | R&D GLU-LINE Hematology Control |
| CFR section: | 864.8625 Hematology quality control |
| mixture. | |
| Device Class: | Class II |
Predicate Device: R&D Systems Glucose Hemoglobin Hematology Control, K993321 manufactured by R&D Systems, Inc. 614 McKinley Place N.E., Minneapolis, MN 55413
Description: This control is a multilevel control that provides a means of measuring the linearity of glucose analyzers for the glucose parameter.
Intended use: R&D GLU-LINE Hematology Control is designed as a multilevel control that provides a means of measuring the linearity of glucose analyzers for the glucose parameter.
Comparison: Both products are used to monitor glucose on hematology instruments.
Discussion: Laboratory testing of 3 validation lots has shown R&D GLU-LINE Hematology Control to have substantial equavalence in performance, precision and stability to the predicate device. R&D GLU-LINE Hematology Control passed the acceptance criteria of remaining within the assay range over the life of the product. R&D GLU-DINE Hematology Control has demonstrated precision as indicated by the small standard deviation obtained during laboratory testing. Expiriation dating has been established at 105 days (closed vial) when stored at 2 - 8° C and handled according to instructons for use.
Conclusion: R&D GLU-LINE Hematology Control is a safe and effective control for the above intended use when used as instructed in the package insert.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three horizontal lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Re:
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 1 0 2004
Mr. Ralph E. Hogancamp Quality Assurance Specialist R & D Systems, Inc. 614 McKinley Place N.E. Minneapolis, MN 55413
K034048 Trade/Device Name: R & D GLU-LINE Hematology Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material(assayed and unassayed) Regulatory Class: Class I Product Code: JJX Dated: December 24, 2003 Received: December 30, 2003
Dear Mr. Hogancamp:
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 complics 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 (301) 594-3084. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Jean M. Cooper, MS, DVM.
Yean M. Cooper, MS, 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
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Device Name: R&D GLU-LINE Hematology Control
Indications for Use:
R&D GLU-LINE Hematology Control is a multilevel control that provides a means of measuring the linearity of glucose analyzers for glucose parameter determinations.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V
OR
Over-The-CounterUse
(Optional Format 1-2-96)
Carl Benson
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k).
(