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

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 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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Bionostics RNA1c Control for NycoCard HbA1c device:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes a control device, not a diagnostic device with performance metrics like sensitivity, specificity, or accuracy for diagnosing a condition. Instead, the "performance" of a control device relates to its stability and its ability to correlate with a predicate control device.

Therefore, the "acceptance criteria" here are drawn from the "Summary of non-clinical tests" and the "Comparison of Technological Characteristics." The reported device performance is then how the new device meets those characteristics or stability claims.

Acceptance Criteria (Derived from Non-Clinical Tests & Characteristics)	Reported Device Performance (RNA1c Control for NycoCard HbA1c)
Stability (Closed Bottle): 9 months at 2-8 C (Predicate)	12 months at 2 - 8 C
Stability (Opened Bottle): 30 days at 2-8 C (Predicate)	30 days at 2 - 8 C
Correlation to Predicate Device: Equivalent measurement values for HbA1c	Optimized to provide measurement values for HbA1c equivalent to the predicate device.
Test Precision and Range: To be verified	(Implicitly verified through correlation, but specific numerical precision is not stated)
Intended Use: Quality control for Axis-Shield NycoCard reader	Yes, explicitly stated
Number of Levels: 2	Yes, explicitly stated
Container: 3 mL clear glass vial with plastic cap	Yes, explicitly stated
Formulation: Glycosolated bovine hemoglobin with polystyrene beads	Yes, explicitly stated
Serology Testing: No human source material (predicate is human)	No serology testing necessary. Non-human source material

2. Sample Sizes Used for the Test Set and Data Provenance

The document does not specify particular "test sets" in the context of individual patient samples. For a control device, the "test set" would refer to the number of control units tested for stability, correlation, and precision.

Sample Size for Stability: Not explicitly stated (e.g., how many vials were tested over the 12-month period for closed bottle stability or 30-day period for opened bottle stability).
Sample Size for Correlation: Not explicitly stated (e.g., how many measurements were taken with the new control vs. the predicate).
Data Provenance: The studies are described as "non-clinical tests" conducted by "Bionostics, Inc." (Devens, MA, USA). The data is retrospective in the sense that these tests were performed prior to submission, but they are directly evaluating the manufactured product to establish its performance characteristics under controlled conditions. This is not patient-data driven but product-performance driven.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This is not applicable to this type of device and study. The "ground truth" for a control material is its chemical composition and its measured value when run on a specific instrument. This is established through analytical chemistry and instrumentation validation, not expert consensus on patient data.

4. Adjudication Method for the Test Set

Not applicable. There is no ambiguous patient data or image interpretation requiring adjudication by experts. The "ground truth" is analytical.

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. This is a quality control material, not a diagnostic device based on human interpretation or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a quality control material, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on:

Analytical Chemistry and Manufacturing Specifications: The known concentration of glycated bovine hemoglobin and dyed polystyrene beads in the control solution.
Reference Method/Predicate Device Comparison: The established performance and values of the predicate device (Primus Liquid Control for GHb/A1c) on the Axis-Shield NycoCard reader serve as a reference for equivalency in the correlation studies.

8. The Sample Size for the Training Set

Not applicable. This is a control material, not a machine learning model. There is no concept of a "training set" in this context.

9. How the Ground Truth for the Training Set Was Established

Not applicable for the same reason as above.

Summary

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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 hemoglobinhemolysate with polystyrene beadsto simulate blood cells.	Liquid, whole blood hemolysateprepared from diabetic and non-diabetic whole bloods.
Intended Use:	As a quality control solution for useto verify the performance of theAxis-Shield NycoCard reader for themeasurement of HbA1c	As a quality control solution for useto verify the performance of theAxis-Shield NycoCard reader for themeasurement 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 plasticcap.

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-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 unopenedProduct:	12 months at 2 - 8 C	9 months at 2 - 8 C
Stability of openedProduct:	30 days at 2 - 8 C	30 days at 2 - 8 C
Color:	Red	Dark red

Description of the new device II.

%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 minimally hazardous liquid control solution containing no human biological materials and requires no reconstitution prior to use.

{2}------------------------------------------------

Intended use of the device (5)

Technological characteristics of the device. (6)

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.

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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 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).

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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

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Indications for Use

ﺒﻲ

510(k) Number (if known): K050961

Device Name: RNA1c Control for NycoCard HbA1c

Indications For Use:

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.

Page 1 of 1

Office of In Vitro Diagnostic
Regulation and Safety

Koso 961

Regulation Number and Section

§ 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.