DOCUMENT SALICYLATE CAL VER

K041073 · Microgenics Corp. · JJY · May 21, 2004 · Clinical Chemistry

Device Facts

• Record ID: K041073
• Device Name: DOCUMENT SALICYLATE CAL VER
• Applicant: Microgenics Corp.
• Product Code: JJY · Clinical Chemistry
• Decision Date: May 21, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The DOCUMENT® Salicylate CAL•VER® solutions are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification, verification of Analytical Measurement Range (AMR) and verification of the reportable range on immunochemistry and clinical chemistry systems for salicylate. Multiple levels are provided to establish the linear relationship between theoretical operation and actual performance. There exists a linear relationship among each of the solutions.

Device Story

DOCUMENT® Salicylate CAL•VER® consists of 5 levels of human serum-based solutions containing salicylate (0–100 mg/dL) with added preservatives. Used in clinical chemistry/immunochemistry laboratories by technicians to verify instrument performance; specifically linearity, calibration, and Analytical Measurement Range (AMR). The device provides a known linear relationship across levels to compare against instrument output. By confirming the instrument's reportable range and linear performance, the device ensures the accuracy of patient salicylate test results, aiding clinicians in therapeutic monitoring and toxicity assessment.

Clinical Evidence

No clinical data. Bench testing performed using SYNCHRON CX4 analyzer with SYNCHRON systems Salicylate reagent. Twenty-one replicates across three runs for each of the five levels demonstrated coefficient of variation (CV) deviations of less than 10%. Traceability established via USP standard.

Technological Characteristics

Liquid human serum matrix with preservatives. Five-level concentration set (0–100 mg/dL). Storage at 2°C to 8°C. Quantitative control material.

Indications for Use

Indicated for in vitro diagnostic use to verify linearity, calibration, and reportable range of salicylate assays on immunochemistry and clinical chemistry systems. No specific patient population or contraindications described.

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

• DOCUMENT® Thyroid CAL·VER® (K992034)

Submission Summary (Full Text)

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

A. 510(k) Number:
K041073

B. Purpose for Submission:
New Device

C. Analyte:
Quality control material (assayed and unassayed)

D. Type of Test:
Quantitative

E. Applicant:
Microgenics Corp.

F. Proprietary and Established Names:
DOCUMENT® Salicylate CAL·VER

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

H. Intended Use:
1. Intended use(s):
The DOCUMENT® Salicylate CAL·VER® solutions are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration, verification, verification of Analytical Measurement Range (AMR) and verification of the reportable range on immunochemistry and clinical chemistry systems for salicylate. Multiple levels are provided to establish the linear relationship between theoretical operation and actual performance. There exists a linear relationship among each of the solutions.
2. Indication(s) for use:
The DOCUMENT® Salicylate CAL·VER® solutions are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration,

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verification, verification of Analytical Measurement Range (AMR) and verification of the reportable range on immunochemistry and clinical chemistry systems for salicylate. Multiple levels are provided to establish the linear relationship between theoretical operation and actual performance. There exists a linear relationship among each of the solutions.

3. Special condition for use statement(s): Not applicable
4. Special instrument Requirements: Not applicable

I. Device Description:
The DOCUMENT® Salicylate CAL·VER® set consists of 5 levels with 5 mL per level of solutions containing salicylate- Levels 1 through 5- with concentrations ranging between 0 to approximately 100 mg/dL salicylate. The base matrix for these solutions is human serum with preservatives added for stability.

J. Substantial Equivalence Information:
1. Predicate device name(s): DOCUMENT® Thyroid CAL·VER®
2. Predicate K number(s): K992034
3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | Assayed or unassayed quality control | Assayed quality control |
| Matrix | Human Serum | Human Serum |
| Control Form | Liquid | Liquid |
| Storage | 2°C to 8° | 2°C to 8° |
| Differences | | |
| Item | Device | Predicate |
| Analytes | Salicylate | Thyroxine (T4)
Triiodothyronine (T3)
Thyroid Stimulating Hormone (TSH) |
| Control Levels | Five target levels | Eight target Levels |

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

L. Test Principle: NA

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 (controls, calibrators, or method):
USP standard

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:
The control was compared with the SYNCRON systems Salicylate reagent on a SYNCHRON CX4 analyzer. Twenty-one replicates were analyzed in three runs for each level and resulted in coefficient of variation deviations of less than 10%.

b. Matrix comparison:
Not Applicable

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 concentrations in the DOCUMENT® Salicylate CAL·VER® set has lot specific values that range from 0 to 100 mg/dL.

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