INTERLAB MICROCAL SERUM CONTROLS

K041871 · Trouble Shooter Consuling, Inc. · JJX · Aug 16, 2004 · Clinical Chemistry

Device Facts

• Record ID: K041871
• Device Name: INTERLAB MICROCAL SERUM CONTROLS
• Applicant: Trouble Shooter Consuling, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Aug 16, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The Microcal Normal and Abnormal Controls are lyophilized human sera intended for use as assayed quality control sera to monitor the precision of cellulose acetate based protein electrophoresis testing methods.

Device Story

Microcal Normal and Abnormal Controls are lyophilized human sera used as quality control material in clinical laboratories. The device serves as a reference standard to monitor the precision and performance of cellulose acetate-based protein electrophoresis testing methods. By comparing results obtained from the control serum against established assay values, laboratory personnel can verify the accuracy and consistency of their electrophoresis procedures. The device is intended for professional use by laboratory technicians to ensure reliable diagnostic testing outcomes.

Clinical Evidence

No clinical data; bench testing only. The device is a quality control material intended for laboratory use to monitor assay precision.

Technological Characteristics

Lyophilized human serum; requires reconstitution with 0.5 mL distilled water. Analyte fractions: Albumin, Alpha 1, Alpha 2, Beta, Gamma. Compatible with cellulose acetate electrophoresis media. Storage: 2-8°C. Reconstituted stability: 12 days at 2-8°C.

Indications for Use

Indicated for use as quality control material for monitoring precision in cellulose acetate-based protein electrophoresis testing. For prescription use only.

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.

Submission Summary (Full Text)

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

A. 510(k) Number: k041871
B. Purpose for Submission: Notification of intent to manufacture and market the device: InterLab Microcal Control Serum for Protein Electrophoresis
C. Analyte: Quality control material (high and low) for the electrophoretic separation of proteins (Albumin, Alpha 1, Alpha 2, Beta, Gamma)
D. Type of Test: N/A
E. Applicant: InterLab Scientific Instruments srl
F. Proprietary and Established Names: Proprietary – InterLab Microcal Serum Controls Established – Quality Control Material (Assayed and Unassayed)
G. Regulatory Information:
1. Regulation section: 21 CFR 862.1660
2. Classification: Class I
3. Product Code: JJX
4. Panel: 75

H. Intended Use:
1. Intended use(s): The Microcal Normal and Abnormal Controls are lyophilized human sera intended for use as assayed quality control sera to monitor the precision of cellulose acetate based protein electrophoresis testing methods.
2. Indication(s) for use: See intended use above.
3. Special condition for use statement(s): For prescription use only
4. Special instrument requirements: Microtech System

I. Device Description: The device consists of lyophilized vials of human sera at a normal and abnormal level. Each vial requires reconstitution with 0.5 mL of

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distilled water. Mean values and ranges for the Microtech System are provided in the labeling.

## J. Substantial Equivalence Information:

1. Predicate device name(s): Kemtol Serum Controls Normal (k920927) and Abnormal (k920926) of Helena Laboratories
2. Predicate K number(s): Kemtol Serum Controls Normal (k920927) and Abnormal (k920926) of Helena Laboratories
3. Comparison with predicate:

| InterLab Microcal Serum Normal and Abnormal Controls | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | InterLab Microcal Normal and Abnormal Controls are lyophilized human sera intended for use as assayed quality control sera to monitor the precision of cellulose acetate based protein electrophoresis testing methods. | Kemtol Serum Control is to be used as a quantitative control for serum protein electrophoresis on cellulose acetate and agarose. It can also be used as a control for hemoglobin binding capacity of serum haptoglobin. |
| Form | Lyophilized | Lypholized |
| Matrix | Human Serum | Human Serum |
| Storage | 2° – 8°C | 2° – 8°C |
| Reconstituted Stability | 12 days @ 2° – 8°C | 5 days @ 2° – 8°C |
| Analytes | Albumin | Albumin |
| | Alpha 1 | Alpha 1 |
| | Alpha 2 | Alpha 2 |
| | Beta | Beta |
| | Gamma | Gamma |
| Levels | Normal & Abnormal | Normal & Abnormal |
| Electrophoresis Support Media | Cellulose Acetate | Cellulose Acetate Agarose |

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K. Standard/Guidance Document Referenced (if applicable): None referenced

L. Test Principle: N/A

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): Lyophilized normal and abnormal control sera were reconstituted according to instructions reported in the insert sheet. Control serum samples were tested by electrophoresis on cellulose acetate supported on Mylar on a Microtech 648 instrument, manufactured by InterLab S. r. I. Electrophoretic tests were assayed using reagents and materials following the test procedure. Precision was calculated for intra-run and inter-run tests.

Lyophilized normal and abnormal control sera was reconstituted after prolonged storage of about 3 years at 2° – 8°C. Preparation of control serum was performed according to the instructions reported in the insert sheet. Control serum samples were tested by electrophoresis on cellulose acetate supported on Mylar on a Microtech 648 instrument manufactured by InterLab S. r. I. The instrument provides densitometric percentages of each band versus the total content on each lane. The reconstituted serum was considered to be stable if mean values of each fraction fall within stated (assigned) ranges. Results demonstrate that the same batch of control serum assayed over multiple lots of strips yielded mean values that were within the stated range percentages over a period of three years.

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:

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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
5. Expected values/Reference range: See the package insert for the assigned values and ranges.

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