(38 days)
RNA1c Control for Bayer DCA2000 and DCA2000+ Analyzers is intended to be used to monitor and evaluate the analytical performance of the Bayer DCA 2000 and DCA 2000+ Analyzers that measure HbA1c. The use of quality control materials is indicated as an objective assessment of the precision of methods and techniques in use and is an integral part of good laboratory practice. The two levels of controls allow performance monitoring within the clinically important range.
For In Vitro Diagnostic Use
RNA1c Hemoglobin A1c Control for Bayer DCA2000 and DCA2000+ Analyzers is a two-level, aqueous liquid control solution consisting of a synthetic peptide identical to the HbA1c epitope in a non-biological aqueous solution with dye to provide the appropriate total hemoglobin value. The concentration of dye and peptide are optimized for use on the Bayer DC A 2000 and DCA 2000+ Analyzers to provide measurement values for HbA1c equivalent to the predicate device, Bayer DCA 2000 Hemoglobin A1c Normal and Abnormal Control Kit.
RNA1c Hemoglobin A1c Control for Bayer DCA2000 and DCA2000+ Analyzers provides a convenient method of performing periodic QC checks for laboratories selecting to measure liquid QC material as a part of their quality assurance program. The product is packaged in a plastic bottle with dropper tip for application of the solution to the test cartridge.
RNA1c Hemoglobin A1c Control for Bayer DCA2000 and DCA2000+ Analyzers is a non-hazardous aqueous solution containing no biological materials and requires no reconstitution prior to use.
The provided text describes the 510(k) summary for the "RNA1c Hemoglobin A1c Control for Bayer DCA2000 and DCA2000+ Analyzers" device. It outlines the device's characteristics, intended use, and a comparison to a predicate device to establish substantial equivalence. However, it does not contain detailed information about specific acceptance criteria or a study that rigorously proves the device meets those criteria with statistical data.
The document states that "Tests were conducted to verify specific performance requirements: a) Closed bottle stability, b) Stability after opening, c) Correlation to predicate device, d) Test precision and range." It also notes that "Comparison of technological characteristics, formulation and intended use to predicate devices listed in this summary support the claim of substantial equivalence."
This document is a regulatory submission for substantial equivalence based on comparison to an existing device, rather than a detailed report of a performance study with specific acceptance criteria and outcome data. Therefore, many of the requested fields cannot be filled from the provided text.
Here's a breakdown of what can and cannot be answered based on the input:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a quantitative manner or report specific performance metrics against such criteria. It generally states that the device provides "measurement values for HbA1c equivalent to the predicate device."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not provided in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as this is a quality control material and the "ground truth" would be established by the analytical performance of the device it controls, not by human expert assessment. The document does not describe the specific methodology for evaluating the "correlation to predicate device" or "test precision and range."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable, as this is a quality control material, not an AI diagnostic device for human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a control solution, which is used to assess the performance of an analyzer (Bayer DCA 2000 and DCA 2000+ Analyzers). The "standalone" performance here refers to the control's ability to produce consistent results on those analyzers. The document indicates tests were done for "Correlation to predicate device" and "Test precision and range," which implies standalone performance evaluation, but no specific data or methodology is provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a quality control material, the "ground truth" for its performance would typically be the assigned value of the control, established through rigorous testing against reference methods or by comparison to an established predicate. The document states the new device is optimized "to provide measurement values for HbA1c equivalent to the predicate device," suggesting the predicate device's performance provides a reference point.
8. The sample size for the training set
Not applicable, as this is a physical control solution, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
Summary of available information regarding acceptance criteria and study:
The document describes the device as a quality control material intended to monitor the analytical performance of HbA1c analyzers. The "study" mentioned consists of non-clinical tests to verify performance requirements through comparison to a predicate device.
| Aspect | Information from Document |
|---|---|
| Acceptance Criteria & Reported Performance | Acceptance Criteria: Not explicitly stated as quantitative thresholds. Implied acceptance is achieving "measurement values for HbA1c equivalent to the predicate device" and meeting stability, precision, and range requirements. Reported Performance: The document concludes that "Comparison of technological characteristics, formulation and intended use to predicate devices listed in this summary support the claim of substantial equivalence." No specific performance data (e.g., precision coefficients, correlation values, stability data within defined limits) is provided. |
| Study Type & Purpose | Non-clinical tests were conducted to verify: a) Closed bottle stability b) Stability after opening c) Correlation to predicate device d) Test precision and range The overall purpose was to demonstrate substantial equivalence to the predicate device (Bayer DCA 2000 Hemoglobin A1c Normal and Abnormal Control Kit [K021484]). |
| Sample Size (Test Set) | Not provided. |
| Data Provenance | Not provided (e.g., country of origin, retrospective/prospective). |
| Number & Qualifications of Experts (Ground Truth) | Not applicable, as this is a QC material, not expert-interpreted data. |
| Adjudication Method | Not applicable. |
| MRMC Comparative Effectiveness Study | Not applicable. |
| Standalone Performance | Yes, implied by tests for "Correlation to predicate device" and "Test precision and range" for the control solution when used on the specified analyzers. No specific data is given. |
| Type of Ground Truth | The "ground truth" for the control material's values would be established reference values or equivalence to the predicate device's expected performance, likely through analytical methods rather than expert consensus or pathology. |
| Training Set Size | Not applicable (not an AI/ML device). |
| Training Set Ground Truth Establishment | Not applicable. |
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FEB 2 5 2005
Image /page/0/Picture/1 description: The image shows the logo for Bionostics Ferraris Quality Solutions. The logo features the word "BIONOSTICS" in bold, sans-serif font on the left side of the image. To the right of the word is a black, semi-circular shape. Below the semi-circle and to the right is the text "FERRARIS Quality Solutions" in a smaller font.
510(k) Summary1
| (a) (1) Submitter's name, address |
|---|
| Bionostics, Inc. |
| 7 Jackson Road |
| Devens, MA 01434 |
Contact Person Kathleen Storro Director, QA & Regulatory Affairs (978) 772-7070 x 220
Date of preparation of this summary: 17 January 2005
- Device trade or proprietary name: (2)
RNA1c Hemoglobin A1c Control for Bayer DCA2000 and DCA2000+ Analyzers
Device common or usual name or classification name:
Glycosylated Hemoglobin Control
| CLASSIFICATION | |||
|---|---|---|---|
| PRODUCT NOMENCLATURE | NUMBER | CLASS | PANEL |
| Control, Single Analyte (Assayed or Unassayed) | 862.1660 (JJX) | I | Chemistry |
I. Substantial Equivalence
RNA1c Hemoglobin A1c Control for Bayer DCA2000 and DCA2000+ Analyzers is substantially equivalent in function, safety and efficacy to Bayer DCA 2000 Hemoglobin A1c Normal and Abnormal Control Kit. [K021484]
| Comparison of Technological Characteristics with Predicate Device |
|---|
| ------------------------------------------------------------------- |
| Characteristic | New Device | Predicate Device |
|---|---|---|
| Name: | RNA1c Hemoglobin A1c Control forBayer DCA 2000 and DCA2000Analyzers | Bayer DCA 2000+ HbA1c Control |
| 510(k), Date: | K021484, 06/14/2002 | |
| Description: | Red, aqueous solution with non-biological synthetic peptide | Lyophilized Hemoglobin Control |
| Intended Use: | As a quality control solution for useto verify the performance of theBayer DCA 2000+ Analyzer for themeasurement of HbA1c | As a quality control lysate to monitorthe precision of laboratoryprocedures for measurement ofHbA1c |
| Number of levels: | 2 | 2 |
| Analytes: | Glycated hemoglobin (HbA1c%) | Glycated hemoglobin (HbA1c%) |
| Container: | plastic bottle | 3.5 mL clear borosilicate glass vialwith plastic screw cap and phenolicmoisture barrier liner. |
1 This summary of safety and effectiveness is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
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| Characteristic | New Device | Predicate Device |
|---|---|---|
| Serology Testing ofHuman SourceMaterial | No serology testing is necessary.Non-biological solution withsynthetic peptide | Non-reactive for:• Hepatitis B Surface Antigen• Antibody to Hepatitis C• Antibody to HIV-1 & HIV-2• Syphilis (TPHA & RPR) |
| Storage: | 2° - 8°C | 2° - 8°C |
| Stability of LyophilizedProduct: | N/A – liquid solution | 3 years at 2° - 8°C |
| Stability in Liquid State(reconstituted) | 12 months at 2° - 8°C | 13 weeks at 2° - 8°C |
| Color: | Red | Dark red (after reconstitution) |
II. Description of the new device
Glycosylated Hemoglobin (HbA1c) is a human hemoglobin A (HbA0) with glucose irreversibly bound to the N-terminal valine of the beta-chain. %HbA1c is the percentage of glycolsylated hemoglobin molecules as a percentage of the total hemoglobin concentration.
%HbA1c is quantified on medical devices by turbidimetric inhibition immunoassay (TINIA), ion-exchange HPLC, boronate affinity HPLC or gel electrophoresis.
The Bayer DCA 2000+ [K940971] determines HbA1c concentration by immunoassay and total hemoglobin concentration by colorimetry. Using the values obtained for each of these two analytes, the percentage of the total hemoglobin that is glycated is calculated and reported as HbA1c%.
RNA1c Hemoglobin A1c Control for Bayer DCA2000 and DCA2000+
Analyzers is a two-level, aqueous liquid control solution consisting of a synthetic peptide identical to the HbA1c epitope in a non-biological aqueous solution with dye to provide the appropriate total hemoglobin value. The concentration of dye and peptide are optimized for use on the Bayer DC A 2000 and DCA 2000+ Analyzers to provide measurement values for HbA1c equivalent to the predicate device, Bayer DCA 2000 Hemoglobin A1c Normal and Abnormal Control Kit.
RNA1c Hemoglobin A1c Control for Bayer DCA2000 and DCA2000+ Analyzers provides a convenient method of performing periodic QC checks for laboratories selecting to measure liquid QC material as a part of their quality assurance program. The product is packaged in a plastic bottle with dropper tip for application of the solution to the test cartridge.
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RNA1c Hemoglobin A1c Control for Bayer DCA2000 and DCA2000+ Analyzers is a non-hazardous aqueous solution containing no biological materials and requires no reconstitution prior to use.
- (5) Intended use of the device
RNA1c Hemoglobin A1c Control for Bayer DCA2000 and DCA2000+ Analyzers is intended to be used to monitor and evaluate the analytical performance of the Bayer DCA 2000 and DCA 2000+ Analyzers.
(6) Technological characteristics of the device.
RNA1c Hemoglobin A1c Control for Bayer DCA2000 and DCA2000+ Analyzers is a two-level, aqueous liquid control solution consisting of a synthetic peptide identical to the HbA1c epitope in a non-biological aqueous solution with dye to provide the appropriate total hemoglobin value. The concentration of dye and peptide are optimized for use on the Bayer DCA 2000 and DCA 2000+ Analyzer to provide measurement values for HbA1c equivalent to the predicate device, Bayer DCA 2000 Hemoglobin A1c Normal and Abnormal Control Kit.
(b) (1) Summary of non-clinical tests submitted with the premarket notification for the device.
Tests were conducted to verify specific performance requirements:
- a) Closed bottle stability
- b) Stability after opening
- c) Correlation to predicate device
- d) Test precision and range
Summary of clinical tests submitted with the premarket notification for the (b) (2) device.
N/A
(b) (3) Conclusions drawn from the clinical and non-clinical trials.
Comparison of technological characteristics, formulation and intended use to predicate devices listed in this summary support the claim of substantial equivalence.
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Image /page/3/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 symbol that resembles a stylized caduceus or a bird-like figure, composed of three curved lines.
FEB 2 5 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Kathleen Storro Director, QA and Regulatory Affairs Bionostics, Inc. 7 Jackson Road Devens, MA 01432
Re: K050100
Trade/Device Name: RNA1c Hemoglobin A1c Control for Bayer DCA2000 and DCA2000+ Analyzers Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assay and unassayed) Regulatory Class: Class I Product Code: JJX Dated: January 17, 2005 Received: January 18, 2005
Dear Ms. Storro:
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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Page 2 -
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)276-0484. 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/industry/support/index.html
Sincerely yours,
Jean M.Cooper MS, DUM
Jean 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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Indications for Use
510(k) Number (if known): K050100
RNA1c Control for Bayer DCA2000 and DCA2000+ Analyzers Device Name:
Indications For Use:
RNA1c Control for Bayer DCA2000 and DCA2000+ Analyzers is intended to be used to monitor and evaluate the analytical performance of the Bayer DCA 2000 and DCA 2000+ Analyzers that measure HbA1c. The use of quality control materials is indicated as an objective assessment of the precision of methods and techniques in use and is an integral part of good laboratory practice. The two levels of controls allow performance monitoring within the clinically important range.
For In Vitro Diagnostic Use
Prescription Use × (Part 21 CFR 801 Subpart D) 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 Device Evaluation (ODE)
Carol C. Benson
Division Sign-Off
Office of a firo Diognostic Devine Bunbation and Sately
510K K050100
Page 1 of
§ 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.