(71 days)
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.
This control is a multilevel control that provides a means of measuring the linearity of glucose analyzers for the glucose parameter.
The information provided describes the R&D Systems, Inc. GLU-LINE Hematology Control, a device designed to measure the linearity of glucose analyzers.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Remains within assay range over product life | Passed the acceptance criteria of remaining within the assay range over the life of the product. |
| Stability | Expiration dating established at 105 days (closed vial) when stored at 2-8°C and handled according to instructions for use. |
| Precision | Demonstrated precision as indicated by the small standard deviation obtained during laboratory testing. |
| Substantial Equivalence to Predicate Device | Laboratory testing of 3 validation lots has shown R&D GLU-LINE Hematology Control to have substantial equivalence in performance, precision and stability to the predicate device (R&D Systems Glucose Hemoglobin Hematology Control, K993321). |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The submission states that 3 validation lots were tested. The specific number of individual samples or measurements within those lots is not provided.
- Data Provenance: The data was generated through "Laboratory testing" and is therefore prospective as it was conducted specifically for the validation of this device. The country of origin is not explicitly stated but can be inferred as the United States, given the company's address in Minneapolis, MN, and the FDA submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable/ not provided in the context of this device. The GLU-LINE Hematology Control is a quality control material intended to assess the performance of glucose analyzers by providing known glucose levels. The "ground truth" for such a device would be the precisely manufactured and calibrated glucose values within the control material itself, not established by human experts interpreting clinical data. Therefore, there's no mention of experts establishing ground truth for the test set in the biological sense. The truth is intrinsic to the product design and manufacturing.
4. Adjudication method for the test set
This information is not applicable / not provided. As explained above, for a quality control material with precisely defined glucose levels, there is no need for expert adjudication of results. The device's performance is assessed against its own intended specifications and its comparison to a predicate device.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. The GLU-LINE Hematology Control is a quality control material; its direct interaction is with an automated instrument, not human readers interpreting cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not directly applicable in the context of this device. The GLU-LINE Hematology Control itself is an inert control material; it doesn't have an "algorithm" in the sense of an AI software. Its performance is measured by how accurately and precisely glucose analyzers read the known glucose concentrations within the control. The study assesses the performance of the control material, not a standalone algorithm.
7. The type of ground truth used
The ground truth for this device is the known, manufactured concentrations of glucose within the control material. These concentrations are established during the product's formulation and manufacturing process, likely through highly precise analytical methods and calibration. The device's performance is then evaluated by how well external analyzers measure these known concentrations.
8. The sample size for the training set
This information is not applicable / not provided. The GLU-LINE Hematology Control is a physical quality control material, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI development.
9. How the ground truth for the training set was established
This information is not applicable / not provided for the same reasons as point 8.
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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. Hogancamp612-656-4413, FAX 612-379-6809 |
| Classification name: | Hematology Quality Control Mixture |
| Product name: | R&D GLU-LINE Hematology Control |
| CFR section: | 864.8625 Hematology quality controlmixture. |
| 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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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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).
(
§ 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.