AUDIT MICROLQ SPINAL FLUID CONTROL

K112742 · Aalto Scientific, Ltd. · JJY · Jun 15, 2012 · Clinical Chemistry

Device Facts

• Record ID: K112742
• Device Name: AUDIT MICROLQ SPINAL FLUID CONTROL
• Applicant: Aalto Scientific, Ltd.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Jun 15, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

Audit® MicroLQ™ Spinal Fluid Control is a quality control material intended for monitoring the precision of laboratory testing procedures. When used for quality control purposes, it is recommended that each laboratory establish its own means and acceptable ranges and use the values provided only as guides. The Audit® MicroLQ™ Spinal Fluid is for In Vitro Diagnostic use only.

Device Story

Audit® MicroLQ™ Spinal Fluid is a human-based, liquid quality control material. It contains 10 analytes: Chloride, Glucose, IgA, IgG, IgM, Lactate, Lactate Dehydrogenase (LD), Microalbumin, Microprotein, and Sodium. Used in clinical laboratories to monitor the precision of testing procedures; helps verify calibration of diagnostic assays. Laboratory personnel use the material to establish internal means and acceptable ranges for test performance. Provides a guide for quality assurance in diagnostic testing; benefits patients by ensuring the accuracy and reliability of clinical laboratory results.

Clinical Evidence

No clinical data. Performance is supported by stability studies confirming a two-year shelf life (unopened at 2-8°C) and 30-day open-vial stability (at 2-8°C).

Technological Characteristics

Human-based serum matrix; liquid form; 10 analytes (Chloride, Glucose, IgA, IgG, IgM, Lactate, LD, Microalbumin, Microprotein, Sodium); stored at 2-8°C; 30-day open-vial stability.

Indications for Use

Indicated for use as an in vitro diagnostic quality control material to monitor the precision of laboratory testing procedures for specific analytes in spinal fluid. No specific patient population is targeted as this 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

• Audit™ MicroCV™ General Chemistry Linearity Set (k101216)

Submission Summary (Full Text)

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

A. 510(k) Number:
k112742

B. Purpose for Submission:
New device

C. Measurand:
Quality control materials for Chloride, Glucose, Immunoglobulin A (IgA), Immunoglobulin G (IgG), Immunoglobulin M (IgM), Lactate, Lactate Dehydrogenase (LD), Microalbumin, Microprotein, and Sodium.

D. Type of Test:
Not applicable

E. Applicant:
Aalto Scientific, Ltd.

F. Proprietary and Established Names:
Audit® MicroLQ™ Spinal Fluid Control

G. Regulatory Information:
| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| JJY | Class I, reserved | 21 CFR§862.1660 | 75 Clinical Chemistry |

H. Intended Use:

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

2. Indication(s) for use:
Audit® MicroLQ™ Spinal Fluid Control is a quality control material intended for monitoring the precision of laboratory testing procedures.
When used for quality control purposes, it is recommended that each laboratory

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establish its own means and acceptable ranges and use the values provided only as guides.

The Audit® MicroLQ™ Spinal Fluid is for In Vitro Diagnostic use only.

3. Special conditions for use statement(s):

The Audit® MicroLQ™ Spinal Fluid Control should not be used for calibration or standardization of the Chloride, Glucose, Immunoglobulin A (IgA), Immunoglobulin G (IgG), Immunoglobulin M (IgM), Lactate, Lactate Dehydrogenase (LD), Microalbumin, Microprotein, and Sodium.

4. Special instrument requirements:

Performance was established on the Beckman Immage 800 and Roche P-Modular analyzers.

I. Device Description:

The Audit® MicroLQ™ Spinal Fluid Control is a human based, liquid set of QC material. Each level of the set contains Chloride, Glucose, Immunoglobulin A (IgA), Immunoglobulin G (IgG), Immunoglobulin M (IgM), Lactate, Lactate Dehydrogenase (LD), Microalbumin, Microprotein, and Sodium analytes. It is used to confirm the proper calibration of Chloride, Glucose, Immunoglobulin A (IgA), Immunoglobulin G (IgG), Immunoglobulin M (IgM), Lactate, Lactate Dehydrogenase (LD), Microalbumin, Microprotein, and Sodium

All human source materials used to produce this product have been tested for HbsAg, anti-HCV, HIV-1 and HIV-2 and found to be non-reactive by FDA cleared/approved tests.

J. Substantial Equivalence Information:

1. Predicate device name(s):

Audit™ MicroCV™ General Chemistry Linearity Set

2. Predicate K number(s):

k101216

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3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | New Device | Predicate |
| Characteristics | Audit® MicroLQ™ Spinal Fluid Control (k112742) | Audit™ MicroCV™ General Chemistry Linearity Set (k101216) |
| Intended Use | The Audit® MicroLQ™ Spinal Fluid Control is a quality control material intended for monitoring the precision of laboratory testing procedures. | Same |
| Analyzers | P-Modular and Beckman Immage 800 | Beckman Immage 800 |
| Format | Liquid | Same |
| Preservatives | Sodium azide | Same |
| Stability | 2-8°C until expiration date | Same |
| Matrix | Human serum | Same |
| Differences | | |
| --- | --- | --- |
| Item | New Device | Predicate |
| Characteristics | Audit® MicroLQ™ Spinal Fluid Control (k112742) | Audit™ MicroCV™ General Chemistry Linearity Set (k101216) |
| Type of Analytes | Chloride, Glucose, Immunoglobulin A (IgA), Immunoglobulin G (IgG), Immunoglobulin M (IgM), Lactate, Lactate Dehydrogenase (LD), Microalbumin, Microprotein, and Sodium. | Alpha-1-Antitrypsin, Complement C3, Complement C4, Immunoglobulin G, Immunoglobulin A, Immunoglobulin M and Transferrin. |
| Number of Analytes | 10 | 7 |
| Levels per set | 2 | 5 |
| Contents | 6 x 3 ml | 5 x 5 ml |
| Open vial stability | 30 days at 2 to 8°C | 24 hours at 2 to 8°C |

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

None were referenced

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L. Test Principle:

Not applicable.

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

Not applicable

b. Linearity/assay reportable range:

Not applicable

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

Traceability

All components of the The Audit® MicroLQ™ Spinal Fluid Control are obtained from a commercial vendor and inspected in-house.

Stability

Shelf life and open vial stability:

Real-time testing at 2-8°C was conducted and is still on-going. The stability study protocol and acceptance criteria have been reviewed and found to be acceptable. The current accelerated stability test results and ongoing real time stability studies support two year shelf life stability and 30 days open vial stability when stored at 2-8°C.

Value Assignment

The control ranges as determined using Beckman Immage 800 analyzer for Immunoglobulin A, Immunoglobulin G, and Immunoglobulin M and Roche Modular-P analyzer for Chloride, Glucose, Lactate, Lactate Dehydrogenase, Microalbumin, Microprotein, and Sodium are provided in the assigned value sheet for each lot release. Values were assigned from replicate measurements as ±15% CV around the mean. Representative values are shown in the table below.

In the labeling the sponsor recommends that each end user laboratory establish its own means and acceptable ranges and use the assigned value sheet as guidance only.

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| Analyte | Reagent | Analyzer | Units | Level 1 Mean | Level 2 Mean |
| --- | --- | --- | --- | --- | --- |
| Chloride | Roche | P-Modular | mEq/L | 124.8 | 76.8 |
| Glucose | Roche | P-Modular | mg/dL | 64 | 34 |
| Lactate | Roche | P-Modular | mmol/L | 2.4 | 36.0 |
| LD | Roche | P-Modular | IU/L | 22 | 50 |
| Microalbumin, | Pointe | P-Modular | mg/dL | 17.1 | 26.4 |
| Microprotein | Pointe | P-Modular | mg/dL | 30.9 | 80.6 |
| Sodium | Roche | P-Modular | mEq/L | 156.3 | 84.7 |
| Immunoglobulin A | Beckman | Immage 800 | mg/dL | 1.20 | 2.85 |
| Immunoglobulin G | Beckman | Immage 800 | mg/dL | 4.77 | 42.74 |
| Immunoglobulin M | Beckman | Immage 800 | mg/dL | 0.800 | 1.689 |

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

3. Clinical studies:

a. Clinical Sensitivity:

Not applicable

b. Clinical specificity:

Not applicable

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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 are provided in the labeling for each specific lot.

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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