(25 days)
No
The device description focuses on a liquid control solution for verifying the performance of a reader, not on the reader itself or any analytical processing that would typically involve AI/ML. The mechanism described is a calculation based on two measured values.
No
This device is a control solution for an in vitro diagnostic reader, used to verify the performance of the reader, not to treat or diagnose a disease.
No
This device is a control material used to verify the performance of a diagnostic device (the Axis-Shield NycoCard HbA1c reader), not a diagnostic device itself.
No
The device description clearly states it is a "liquid control solution" packaged in a "glass bottle," indicating it is a physical material, 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 a control material used to verify and monitor the performance of an in vitro diagnostic device (the Axis-Shield NycoCard HbA1c reader) which measures a substance (glycosylated hemoglobin) in a biological sample (presumably blood, although not explicitly stated for the control itself, it's used with a reader that measures HbA1c).
- Context: The description places the use of this control within the context of "good laboratory practice" and "quality assurance program," which are standard practices in clinical laboratories performing in vitro diagnostic testing.
Therefore, based on the provided information, the RNA1c Control for NycoCard HbA1c is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
RNA1c Control for NycoCard HbA1c is intended for use to verify the performance of the Axis-Shield NycoCard HbA1c reader with normal and elevated glycosylated hemoglobin levels within the reportable range.
RNA1c Control for NycoCard HbA1c is intended to be used to monitor and evaluate the analytical performance of the Axis-Shield NycoCard HbA1c reader for the measurement of glycosylated hemoglobin. 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 807 Subpart C)
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 Axis-Shield NycoCard reader[K993131] determines HbA1c concentration by the boronate affinity test principle and hemoglobin concentration photometrically. 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 Control for NycoCard HbA1c is a two-level, glycated bovine hemoglobin liquid control solution with dyed polystyrene beads to provide the appropriate total hemoglobin value. The concentration of dyed beads and glycated hemoglobin are optimized for the Axis-Shield NycoCard reader to provide measurement values for HbA1c equivalent to the predicate device, Primus Liquid Control for GHb/A1c.
RNA1c Control for NycoCard HbA1c 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 glass bottle.
RNA1c Control for NycoCard HbA1c is a minimally hazardous liquid control solution containing no human biological materials and requires no reconstitution prior to use.
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:
- Closed bottle stability
- Stability after opening
- Correlation to predicate device
- 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
C050961
MAY 1 3 2005
BIONOSTICS
510(k) Summary1
- Submitter's name, address (a) (1) Bionostics, Inc. 7 Jackson Road Devens, MA 01434
Contact Person Kathleen Storro Sr.Director, QA & Regulatory Affairs (978) 772-7070 x 220
Date of preparation of this summary: 15 April 2005
- RNA1c Control for NycoCard HbA1c Device trade or proprietary name: (2)
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) | 1 | Chemistry |
I. Substantial Equivalence
HbA1c Control for Axis-Shield NycoCard is substantially equivalent in function, safety and efficacy to Primus Liquid Control for GHb/A1c [K992921].
Comparison of Technological Characteristics with Predicate Device
| Characteristic | New Device | Predicate Device |
|---|---|---|
| Name: | RNA1c Control for NycoCard HbA1c | Primus Liquid Control for GHb/A1c |
| 510(k), Date: | K992921, 11/12/1999 | |
| Description: | Glycosolated bovine hemoglobin | |
| hemolysate with polystyrene beads | ||
| to simulate blood cells. | Liquid, whole blood hemolysate | |
| prepared from diabetic and non- | ||
| diabetic whole bloods. | ||
| Intended Use: | As a quality control solution for use | |
| to verify the performance of the | ||
| Axis-Shield NycoCard reader for the | ||
| measurement of HbA1c | As a quality control solution for use | |
| to verify the performance of the | ||
| Axis-Shield NycoCard reader for the | ||
| measurement of HbA1c | ||
| Number of levels: | 2 | 2 |
| Analytes: | Glycated hemoglobin (HbA1c%) | Glycated hemoglobin (HbA1c%) |
| Container: | 3 mL clear glass vial with plastic cap | 1 mL clear glass vial with plastic |
| cap. |
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-human source material | Non-reactive for: | |
| • Hepatitis B Surface Antigen | ||
| • Antibody to Hepatitis C | ||
| • Antibody to HIV | ||
| Storage: | 2 - 8 C, or -20 C | 2 - 8 C |
| Stability of unopened | ||
| Product: | 12 months at 2 - 8 C | 9 months at 2 - 8 C |
| Stability of opened | ||
| Product: | 30 days at 2 - 8 C | 30 days at 2 - 8 C |
| Color: | Red | Dark red |
Description of the new device II.
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 Axis-Shield NycoCard reader[K993131] determines HbA1c concentration by the boronate affinity test principle and hemoglobin concentration photometrically. 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 Control for NycoCard HbA1c is a two-level, glycated bovine hemoglobin liquid control solution with dyed polystyrene beads to provide the appropriate total hemoglobin value. The concentration of dyed beads and glycated hemoglobin are optimized for the Axis-Shield NycoCard reader to provide measurement values for HbA1c equivalent to the predicate device, Primus Liquid Control for GHb/A1c.
RNA1c Control for NycoCard HbA1c 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 glass bottle.
RNA1c Control for NycoCard HbA1c is a minimally hazardous liquid control solution containing no human biological materials and requires no reconstitution prior to use.
2
Intended use of the device (5)
RNA1c Control for NycoCard HbA1c is intended for use to verify the performance of the Axis-Shield NycoCard HbA1c reader with normal and elevated glycosylated hemoglobin levels within the reportable range.
Technological characteristics of the device. (6)
RNA1c Control for NycoCard HbA1c is a two-level, glycated bovine hemoglobin liquid control solution with dyed polystyrene beads to provide the appropriate total hemoglobin value. The concentration of dyed beads and glycated hemoglobin are optimized for the Axis-Shield NycoCard reader to provide measurement values for HbA1c equivalent to the predicate device, Primus Liquid Control for A1c/GHb.
Summary of non-clinical tests submitted with the premarket notification for (b) (1) 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
Conclusions drawn from the clinical and non-clinical trials. (b) (3)
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 consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular fashion around the symbol. The logo is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 1 3 2005
Ms. Kathleen Storro Director, QA and Regulatory Affairs Bionostics, Inc. 7 Jackson Road Devens, MA 01434
Re: K050961
Trade/Device Name: RNA/c Control for NycoCard HbA1c Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJX Dated: April 15, 2005 Received: April 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) This ictief will anow you to organ mailing of substantial equivalence of your device to a legally promation notification - 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 of quostions on the prome 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 Fou may outline 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,
Carol C. Benem
Carol C. Benson, M.A. Acting 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
ﺒﻲ
510(k) Number (if known): K050961
Device Name: RNA1c Control for NycoCard HbA1c
Indications For Use:
RNA1c Control for NycoCard HbA1c is intended to be used to monitor and evaluate the analytical performance of the Axis-Shield NycoCard HbA1c reader for the measurement of glycosylated hemoglobin. 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 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
ન્દ્ર
Albert C.
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Office of In Vitro Diagnostic
Regulation and Safety
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