RNA1C CONTROL FOR NYCOCARD HBA1C

K050961 · Bionostics, Inc. · JJX · May 13, 2005 · Clinical Chemistry

Device Facts

• Record ID: K050961
• Device Name: RNA1C CONTROL FOR NYCOCARD HBA1C
• Applicant: Bionostics, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: May 13, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

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.

Device Story

RNA1c Control is a two-level, liquid quality control solution used to verify the performance of the Axis-Shield NycoCard HbA1c reader. The device consists of glycated bovine hemoglobin and dyed polystyrene beads, which simulate blood cells and provide total hemoglobin values. It is used by laboratory personnel to perform periodic quality control checks. The control is designed to be compatible with the NycoCard reader's boronate affinity test principle and photometric hemoglobin measurement. By providing known values for HbA1c, the control allows clinicians to monitor the precision and accuracy of the reader, ensuring reliable results for patient HbA1c testing. The product is a non-human, minimally hazardous liquid that requires no reconstitution.

Clinical Evidence

No clinical data. Bench testing only, including closed bottle stability, stability after opening, correlation to predicate device, and test precision/range.

Technological Characteristics

Two-level liquid control solution containing glycated bovine hemoglobin and dyed polystyrene beads. Packaged in 3 mL clear glass vials with plastic caps. Optimized for boronate affinity and photometric measurement principles. Storage at 2-8°C or -20°C. Non-human source material; no serology testing required.

Indications for Use

Indicated for use as a quality control material to monitor analytical performance of the Axis-Shield NycoCard HbA1c reader for glycosylated hemoglobin measurement in laboratory settings.

Regulatory Classification

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.

Predicate Devices

• Primus Liquid Control for GHb/A1c (k992921)

Submission Summary (Full Text)

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
DEVICE ONLY TEMPLATE

A. 510(k) Number:
k050961

B. Purpose for Submission:
New Device

C. Analyte:
Glycosylated Hemoglobin

D. Type of Test:
Control Material

E. Applicant:
Bionostics, Inc.

F. Proprietary and Established Names:
RNA1a Control for NycoCard HcA1c

G. Regulatory Information:
1. Regulation section:
21 CFR 862.1660 Quality control material (assayed and unassayed).
2. Classification:
Class I, reserved
3. Product Code:
JJX
4. Panel:
75, Chemistry

H. Intended Use:
1. Intended use(s):
See Indications for Use below.
2. Indication(s) for use:
RNA1a Control for NycoCard HcA1c 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 within the clinically important range. For In Vitro Diagnostic Use.
3. Special condition for use statement(s):
For Prescription Use Only.
4. Special instrument Requirements:
Axis-Shield NycoCard HbA1c test system.

I. Device Description:
RNA1c Control is for the NycoCard HbA1c reader. The bi-level (abnormal and normal) glycated bovine hemoglobin liquid control contains no human biological material and does not require reconstitution. The control is supplied in two 1.5 mL vials and contains beads, buffers, viscosity adjusters and stabilizers.

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The bovine blood sourced from US disease-free cattle and this product can be provided with certificate of health from the USDA Veterinary Services.

# J. Substantial Equivalence Information:

1. Predicate device name(s): Primus Liquid Control for GHb/A1c
2. Predicate K number(s): k992921
3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | Intended to be used to monitor and evaluate the analytical performance of the Axis-Shield NycoCard HbA1c reader for the measurement of glycosylated hemoglobin. | For the control of quantitative glycated hemoglobin assays. |
| Number of Levels | 2 | 2 |
| Analytes | Glycated hemoglobin (HbA1c) | Glycated hemoglobin (HbA1c) |
| Open Vial Stability | 30 days at 2-8 °C | 30 days at 2-8 °C |
| Storage | 2-8 °C | 2-8 °C |
| Differences | | |
| Item | Device | Predicate |
| Closed Stability | 12 months at 2-8 °C | 9 months at 2-8 °C |
| Matrix | Glycated bovine hemoglobin in solution with dyed polystyrene beads to simulate total hemoglobin. | Lyophilised, prepared non-diabetic hemolysate. Abnormal level prepared by controlled glycation. |

# K. Standard/Guidance Document Referenced (if applicable):

Points to consider guidance document on assayed and unassayed quality control material. US FDA, Feb 2 1999

Use of symbols on labels and in labeling of in vitro diagnostic devices intended for professional use, US FDA, Nov 30, 2004.

ISO 13485:2003. Quality Systems: Medical Devices- particular requirements for the application of ISO 9001

ISO 14971:2000. Medical Devices: Application of risk analysis to medical devices.

ISO 15223:2002. Medical Devices- Symbols to be used with medical devices labels, labeling and information to be supplied.

# L. Test Principle:

Not Applicable

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# M. Performance Characteristics (if/when applicable):

1. Analytical performance:
a. Precision/Reproducibility: N/A
b. Linearity/assay reportable range: N/A
c. Traceability (controls, calibrators, or method):
Assigned ranges for the controls are based on replicate assays of representative samples of the product on multiple instruments and lots. Value assigned by this method were evaluated against replicate assays of representative samples (10 tests for each control type) of the product by participating laboratories using the Axis-Shield NycoCard HbA1c reader. The acceptance criterion is a reading of greater than 95% of values reported within assay limits for both the product and the predicate device.
Stability
Closed vial stability was conducted and evaluated at -20 and 5 °C. Evaluation to determine the change from the value at time zero to show less than 10% change in HbA1c recovery over 12 months when stored at -20 or 2-8 °C. The result for normal was 6% and for abnormal was -5%.
Open vial stability was evaluated by testing percent change of HbA1c in vials stored at 2-8 °C daily for 30 days. The percent change in HbA1c over 30 days was -1.4% and +1.8% for normal and abnormal lots respectively.
d. Detection limit: N/A
e. Analytical specificity: N/A
f. Assay cut-off: N/A

2. Comparison studies:
a. Method comparison with predicate device: N/A
b. Matrix comparison: N/A

3. Clinical studies:
a. Clinical sensitivity: N/A
b. Clinical specificity: N/A
c. Other clinical supportive data (when a and b are not applicable): N/A

4. Clinical cut-off: N/A

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5. Expected values/Reference range:
N/A

N. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.