DROPPER A1C DIABETES CONTROL

K103744 · Quantimetrix Corp. · JJX · May 12, 2011 · Clinical Chemistry

Device Facts

• Record ID: K103744
• Device Name: DROPPER A1C DIABETES CONTROL
• Applicant: Quantimetrix Corp.
• Product Code: JJX · Clinical Chemistry
• Decision Date: May 12, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The Quantimetrix Dropper Alc Diabetes Control is intended for the quality control of laboratory procedures used to quantitate HbA1c.

Device Story

Dropper A1c Diabetes Control is a quality control material for HbA1c laboratory assays. It consists of two levels of frozen liquid whole blood matrix, fortified with reagent-grade chemicals to represent threshold and pathological HbA1c ranges. The device is used in clinical laboratory settings to verify the accuracy and precision of HbA1c testing procedures on specific analyzers (e.g., Beckman Coulter Synchron, Roche Cobas, Siemens DCA 2000/Vantage). Laboratory technicians use the control by running it through the same analytical process as patient samples. By comparing the measured HbA1c values against the established mean and range provided for each analyzer, clinicians ensure the reliability of patient test results, thereby supporting accurate diabetes management and monitoring.

Clinical Evidence

No clinical data. Performance is based on analytical value assignment and stability testing. Value assignment was conducted by running each control level once per day for three days across multiple operators on specified analyzers. Stability was validated via accelerated and real-time studies to support claims for closed and open vial storage durations.

Technological Characteristics

Frozen liquid whole blood matrix; fortified with reagent-grade chemicals; contains preservatives to inhibit microbial growth. Two levels provided: threshold and pathological. Compatible with specific clinical chemistry analyzers. Stability: Closed vial (180 days at 2-8°C), Open vial (180 days at 2-8°C or 21 days at 18-25°C).

Indications for Use

Indicated for use as a quality control material for laboratory procedures measuring HbA1c levels. No specific patient population, age, or gender restrictions apply as it is a laboratory control product.

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

• MAS Diabetes Control (k023307)

Submission Summary (Full Text)

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

A. 510(k) Number:
k103744

B. Purpose for Submission:
New Device

C. Measurand:
Quality control material for Hemoglobin A1c (HbA1c)

D. Type of Test:
Not applicable

E. Applicant:
Quantimetrix Corporation

F. Proprietary and Established Names:
Dropper A1c Diabetes Control

G. Regulatory Information:

| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| JJX | Class I, reserved | 21 CFR § 862.1660, Quality control material (assayed and unassayed). | Clinical Chemistry (75) |

H. Intended Use:

1. Intended use(s):
See indications for use below.

2. Indication(s) for use:
The Quantimetrix Dropper A1c Diabetes Control is intended for the quality control of laboratory procedures used to quantitate HbA1c.

3. Special conditions for use statement(s):
For prescription use only.

4. Special instrument requirements:
Beckman Coulter Synchron, Ortho-Clinical Vitros, Primus Corporation
PDQ/Ultra, Roche Cobas Integra, Roche Diagnostics Hitachi, Siemens Healthcare
Diagnostics DCA 2000/Vantage and Siemens Healthcare Diagnostics Dimension

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I. Device Description:

The Dropper A1c Diabetes Control consists of two levels; one level represents Hb1A1c near the threshold level and one in the pathological range. The controls are supplied as a ready to use frozen liquid, requiring no reconstitution or dilution. They are prepared in a whole blood matrix fortified to target levels with reagent grade chemicals added to achieve the two levels. Preservatives have been added to inhibit microbial growth.

J. Substantial Equivalence Information:

| Predicate device name | Predicate 510(k) number |
| --- | --- |
| MAS Diabetes Control | k023307 |

Comparison with predicate:

| Similarities and Differences | | |
| --- | --- | --- |
| Item | New Device | Predicate Device (k023307) |
| Indications for Use | Same | Assayed quality control material for monitoring Glycoslated Hemoglobin (A1c) assay procedures. |
| Analyte | Same | Hemoglobin A1c |
| Matrix | Same | Frozen liquid whole blood |
| Number of Levels | Same | Two |
| Composition | Reagent grade chemicals and constituents of human origin | Pure chemicals and constituents of human origin |
| Stability | Closed Vial: 3 years at -10 to -30°C 180 days at 2 to 8°C | Closed Vial: 2 years at -15 to -25°C 60 days at 2 to 8°C |
| | Open Vial: 180 days at 2 to 8°C 21 days at 18 to 25°C | Open Vial: 21 days at 2 to 8°C |

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

None were referenced.

L. Test Principle:

Not applicable

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

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Not applicable

b. Linearity/assay reportable range: Not applicable

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

Traceability

The Hemoglobin A1c material is traced to a National Glycohemoglobin Standardization Program (NGSP) Certified testing method performed on Siemens Dimension RxL and DCA 2000+ analyzers.

Value Assignment

The Dropper A1c Diabetes Control consists of two levels of Hemoglobin A1c (Hb1A1c); one level near the threshold level (Level 1) and one in the pathological range (Level 2). Value assignment is performed by running each level once per day on each analyzer for three days by two or more different operators (six or more tests per analyzer). All values for each analyzer are inputted and the range for each level is set at $\pm 20\%$ from the calculated mean value. The mean and ranges for Level 1 and 2 are provided for each analyzer in the table below.

| Analyzer | Level 1 | | Level 2 | |
| --- | --- | --- | --- | --- |
| | Mean (%) | Expected Range (%) | Mean (%) | Expected Range (%) |
| Beckman Coulter Synchron | 5.9 | 4.7 - 7.1 | 10.3 | 8.2 - 12.3 |
| Ortho-Clinical Vitros | 6.1 | 4.9 - 7.3 | 10.4 | 8.3 - 12.5 |
| Primus Corporation PDQ/Ultra | 8.3 | 6.6 - 9.9 | 17.7 | 14.1 - 21.2 |
| Roche Cobas Integra | 6.1 | 4.9 - 7.3 | 10.3 | 8.3 - 12.4 |
| Roche Diagnostics Hitachi | 5.2 | 4.1 - 6.2 | 15.3 | 12.3 - 18.4 |
| Siemens Healthcare Diagnostics DCA 2000/Vantage | 5.9 | 4.8 - 7.1 | 8.8 | 7.1 - 10.6 |
| Siemens Healthcare Diagnostics Dimension | 6.2 | 4.9 - 7.4 | 10.3 | 8.3 - 12.4 |
| Analyzer | Level 1 | | Level 2 | |
| --- | --- | --- | --- | --- |
| | Mean (mmol/mol) | Expected Range (mmol/mol) | Mean (mmol/mol) | Expected Range (mmol/mol) |
| Beckman Coulter Synchron | 41 | 28 - 54 | 89 | 66 - 111 |
| Ortho-Clinical Vitros | 43 | 30 - 56 | 90 | 67 - 113 |
| Primus Corporation PDQ/Ultra | 43 | 31 - 56 | 90 | 67 - 113 |
| Roche Diagnostics Hitachi | 43 | 31 - 56 | 90 | 67 - 113 |
| Siemens Healthcare Diagnostics DCA 2000/Vantage | 43 | 31 - 56 | 90 | 67 - 113 |

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| Primus Corporation PDQ/Ultra | 67 | 49 - 85 | 170 | 131 - 208 |
| --- | --- | --- | --- | --- |
| Roche Cobas Integra | 43 | 30 - 56 | 89 | 67 - 112 |
| Roche Diagnostics Hitachi | 33 | 21 - 44 | 144 | 111 - 178 |
| Siemens Healthcare Diagnostics DCA 2000/Vantage | 41 | 29 - 54 | 73 | 54 - 92 |
| Siemens Healthcare Diagnostics Dimension | 44 | 30 - 57 | 89 | 67 - 112 |

**Stability:**

The closed vial stability was evaluated in accelerated and real-time stability studies. Unopened vials stored at 25°C (test material) or 37°C (test material) were tested against unopened vials stored at -10°C to -30°C (reference material) at predetermined time points during a 6 month interval. Based upon accelerated study data, the sponsor claims closed vial stability of 180 days at 2 to 8°C. Real-time stability study is on-going.

The open vial stability was evaluated in accelerated and real-time stability studies. Opened vials stored at 37°C (test material) were tested in duplicate against unopened vials stored at -10°C to -30°C (reference material) at predetermined time points during a 6 month interval. In a second real-time stability study, opened vials stored at 25°C (test material) were tested in duplicate against unopened vials stored at -10°C to -30°C (reference material) at five time points during a 1 month interval. Based upon accelerated and a real-time stability studies, the sponsor claims open vial stability of 180 days at 2 to 8°C or 21 days at 18 to 25°C.

d. Detection limit:
Not applicable

e. Analytical specificity:
Not applicable

f. Assay cut-off:
Not applicable

2. Comparison studies:

a. Method comparison with predicate device:
Not applicable

b. Matrix comparison:
Not applicable

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

4. Clinical cut-off: Not applicable

5. Expected values/Reference range: The expected values on each analyzer are presented in the labeling.

N. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

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

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