R&D GLU-LINE HEMATOLOGY CONTROL

K034048 · R&D Systems, Inc. · JJX · Mar 10, 2004 · Clinical Chemistry

Device Facts

• Record ID: K034048
• Device Name: R&D GLU-LINE HEMATOLOGY CONTROL
• Applicant: R&D Systems, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Mar 10, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The R & D GLU-LINE Hematology Control is a multilevel control that provides a means of measuring the linearity of glucose analyzers for glucose determinations

Device Story

Multilevel control material used to monitor glucose analyzers; provides means of measuring linearity for glucose parameter. Used in laboratory settings by clinical personnel to verify instrument performance. Product remains within assay range over 105-day shelf life when stored at 2-8°C. Helps ensure accuracy and reliability of glucose measurements on hematology instruments.

Clinical Evidence

No clinical data. Bench testing only; mean values derived from replicate analysis using manufacturer-supported reagents.

Technological Characteristics

Multilevel hematology quality control mixture. Liquid-based control for glucose parameter linearity. Storage requirement: 2-8°C. Shelf life: 105 days (closed vial).

Indications for Use

Indicated for use as a multilevel control to measure the linearity of glucose analyzers for glucose parameter determinations in a laboratory setting.

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

• R&D Systems Glucose Hemoglobin Hematology Control (K993321)

Submission Summary (Full Text)

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

A. 510(k) Number: k034048
B. Analyte: Glucose
C. Type of Test: Quality Control Material
D. Applicant: R & D Systems, Inc.
E. Proprietary and Established Names: R& D Systems, Inc. GLU-LINE Linearity Control

F. Regulatory Information:
1. Regulation section: 21 CFR §862.1660
2. Classification: Class I
3. Product Code: JJX
4. Panel: 75

G. Intended Use:
1. Intended use(s):
The R & D GLU-LINE Hematology Control is a multilevel control that provides a means of measuring the linearity of glucose analyzers for glucose determinations

2. Indication(s) for use:
The R & D GLU-LINE Hematology Control is a multilevel control that provides a means of measuring the linearity of glucose analyzers for glucose determinations.

3. Special condition for use statement(s): Prescription use
4. Special instrument Requirements: Glucose instruments

H. Device Description:
The GLU-LINE is an in vitro diagnostic reagent composed of human erythrocytes and glucose suspended in a plasma-like fluid with preservatives. This control is a

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multilevel control that provides a means of measuring the linearity of glucose analyzers for the glucose parameter.

# I. Substantial Equivalence Information:

1. Predicate device name(s):

R & D Systems, Inc. Glucose Hemoglobin Hematology Control

2. Predicate K number(s): K993321
3. Comparison with Predicate:

The R&D GLU-LINE Hematology Control is equivalent to the R&D Glu/Hgb Hematology Control cleared via (K993321). The table below lists the similarities and differences between the Predicate and Proposed device.

| Characteristic | Proposed Device: R&D GLU-LINE Hematology Control K034048 | Predicate Device R&D Glu/Hgb Hematology Control K993321 |
| --- | --- | --- |
| Intended Use | GLU-LINE is a multilevel control that provides a means of measuring the linearity of glucose analyzers for glucose parameter determinations. | Similar |
| Summary | CAP requirements and CLIA regulations both mandate that laboratories establish reportable range for each test method. It is good laboratory practice to verify reportable ranges at initial set up of analyzer, unusual trend or shift in controls and as recommended by the instrument manufacturer. | Similar |
| Reagents | GLU-LINE is an in vitro diagnostic reagent composed of human erythrocytes and glucose suspended in a plasma-like fluid with preservatives. | Similar |
| Storage | Store at 2 - 8°C when not in use. Protect vials from overheating and freezing. | Similar |
| Closed Vial Stability | Unopened vials are stable through the expiration date. | Similar |
| Open Vial Stability | Sampled product should be used immediately, and then discarded. | Similar |

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| Product Description | The GLU-LINE is an in vitro diagnostic reagent composed of human erythrocytes and glucose suspended in a plasma-like fluid with preservatives. This control is a multilevel control that provides a means of measuring the linearity of glucose analyzers for the glucose parameter. | Is used to monitor the results of analyzers that measure glucose and hemoglobin in whole blood. |
| --- | --- | --- |
| Precautions | GLUC-LINE is intended for in vitro diagnostic use only by trained personnel. | Similar |
| Indications of Deterioration | After mixing, the product should be similar in appearance to fresh whole blood. In unmixed tubes, the supernatant may appear cloudy and reddish; This is normal and does not indicate deterioration. Other discoloration, very dark red supernatant or unacceptable results may indicate deterioration. | Similar |
| Limitations | The performance of this product is assured only if it is properly stored and used as described in the package insert. Incomplete mixing of the vial prior to use invalidates both the sample withdrawn and any remaining material in the vial. | Similar |
| Parameters | Glucose | Hemoglobin and Glucose |

J. Standard/Guidance Document Referenced (if applicable):
FDA guidance “Points to Consider Guidance Document on Assayed and Unassayed Quality Control Materials”.

K. Test Principle: NA

L. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility: NA
b. Linearity/assay reportable range: NA

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c. Traceability (controls, calibrators, or method):

The mean values were derived from replicate analysis. The tests listed in the labeling were performed by the reagent manufacturer and/or independent laboratories using manufacturer supported reagents.

d. Detection limit: NA
e. Analytical specificity: NA
f. Assay cut-off: NA

2. Comparison studies:
a. Method comparison with predicate device: NA
b. Matrix comparison: NA

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

4. Clinical cut-off: NA

5. Expected values/Reference range:

GLU-LINE is prepared by precise dilutions of concentrates stock. The obtained mean will be evaluated against the expected value. The difference between the obtained values and the expected values is compared to acceptable limits. Each lab must define its own acceptable limits that can be used by the laboratory director to establish acceptable analytical performance criteria and a reportable range to ensure test results are consistent with the medical needs of the patient.

M. Conclusion:

Based on the review of the information provided in this submission, I recommend that this device is substantially equivalent to the predicate device R&D Glu/Hgb Hematology Control (K993321), regulated by § 21 CFR 862.1660, Single (Specified) Analyte Controls (assayed and unassayed); 75 JJX; Class I