(38 days)
No
The device description and intended use clearly define it as a quality control solution for an existing analyzer, not a device that performs analysis or incorporates computational intelligence. The text explicitly states "Mentions AI, DNN, or ML: Not Found".
No
The device is a quality control material intended to monitor the performance of diagnostic analyzers, not to directly treat or diagnose a patient condition.
No
Explanation: This device is a control material used to monitor and evaluate the performance of diagnostic analyzers (Bayer DCA 2000 and DCA 2000+ Analyzers), not to directly diagnose a disease or condition in a patient. It is explicitly labeled "For In Vitro Diagnostic Use," but specifically as a "Control" rather than a diagnostic test itself.
No
The device is a liquid control solution, which is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For In Vitro Diagnostic Use".
- Purpose: The device is intended to "monitor and evaluate the analytical performance of the Bayer DCA 2000 and DCA 2000+ Analyzers that measure HbA1c." This is a classic function of an IVD control material, used to ensure the accuracy and reliability of diagnostic tests performed outside of the body (in vitro).
- Context: The description places the device within the context of "good laboratory practice" and "quality assurance program," which are integral to the use of IVD devices in a laboratory setting.
N/A
Intended Use / Indications for Use
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.
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
Product codes (comma separated list FDA assigned to the subject device)
JJX
Device Description
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.
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.
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.
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)
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
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.
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
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 for | |
| Bayer DCA 2000 and DCA2000 | ||
| Analyzers | 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 use | |
| to verify the performance of the | ||
| Bayer DCA 2000+ Analyzer for the | ||
| measurement of HbA1c | As a quality control lysate to monitor | |
| the precision of laboratory | ||
| procedures for measurement of | ||
| HbA1c | ||
| Number of levels: | 2 | 2 |
| Analytes: | Glycated hemoglobin (HbA1c%) | Glycated hemoglobin (HbA1c%) |
| Container: | plastic bottle | 3.5 mL clear borosilicate glass vial |
| with plastic screw cap and phenolic | ||
| moisture barrier liner. |
1 This summary of safety and effectiveness is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
1
| Characteristic | New Device | Predicate Device |
|---|---|---|
| Serology Testing of | ||
| Human Source | ||
| Material | No serology testing is necessary. | |
| Non-biological solution with | ||
| synthetic 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 Lyophilized | ||
| Product: | 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.
2
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.
3
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).
4
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
5
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
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