AUDIT(R) MICROLQ(TM) SERUM PROTEIN CONTROL

K112705 · Aalto Scientific, Ltd. · JJY · Jan 24, 2012 · Clinical Chemistry

Device Facts

• Record ID: K112705
• Device Name: AUDIT(R) MICROLQ(TM) SERUM PROTEIN CONTROL
• Applicant: Aalto Scientific, Ltd.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Jan 24, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

Audit® MicroLQ™ Serum Protein Control is an assayed, ready-to-use liquid, bi-level, human serum -based control for use with assays designed to quantitate: Immunoglobulin E (IgE), Immunoglobulin M (IgM), Immunoalobulin G (IgG), Immunoqlobulin A (IgA), Prealbumin, Antithrombin III. Alpha-1-Antitrypsin (AAT). Albumin. Complement C4 (C4). Complement C3 (C3), alpha-2-Macroglobulin, Alpha-1-Acid Glycoprotein, Ceruloplasmin, Transferrin, Haptoglobin, and Beta-2-Microglobulin. It is intended to simulate human patient samples for the purpose of monitoring the precision of laboratory testing procedures for Immunoglobulin E (IgE), Immunoglobulin M (IgM), Immunoglobulin G (IgG), Immunoglobulin A (IgA), Prealbumin, Antithrombin III, Alpha-1-Antitrypsin (AAT), Albumin, Complement C4 (C4), Complement C3 (C3), alpha-2-Macroglobulin, Alpha-1-Acid Glycoprotein, Ceruloplasmin, Transferrin, Haptoglobin, and Beta-2-Microglobulin assays. 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 product is intended for use with quantitative assays on the Beckman Immage 800. The Audit® MicroLQ™ Serum Protein Control is for In Vitro Diagnostic use only.

Device Story

Audit® MicroLQ™ Serum Protein Control is a human serum-based, liquid, bi-level quality control material. It contains 16 specific analytes, including various immunoglobulins, complement proteins, and transport proteins. The device is used in clinical laboratories to monitor the precision of quantitative assays performed on the Beckman Immage 800 analyzer. By simulating human patient samples, the control allows laboratory personnel to verify that testing procedures are performing within established acceptable ranges. It does not perform analysis itself; rather, it serves as a reference material to detect systematic analytical deviations. Healthcare providers use the resulting quality control data to ensure the accuracy and reliability of patient test results, thereby supporting clinical decision-making.

Clinical Evidence

No clinical data. Bench testing only. Value assignment performed on Beckman Immage 800 analyzer using 15 measurements over three days to establish target means. Target ranges calculated as ±15% of target value. Stability established via accelerated stability study (30 days stress) with confirmatory real-time testing ongoing.

Technological Characteristics

Human serum-based liquid control; bi-level; contains 16 analytes (IgE, IgM, IgG, IgA, Prealbumin, Antithrombin III, AAT, Albumin, C4, C3, alpha-2-Macroglobulin, Alpha-1-Acid Glycoprotein, Ceruloplasmin, Transferrin, Haptoglobin, Beta-2-Microglobulin). Storage at 2-8°C. Open-bottle stability of 36 months at 2-8°C.

Indications for Use

Indicated for use as an assayed, bi-level, human serum-based quality control material to monitor the precision of laboratory testing procedures for 16 specific serum protein analytes (IgE, IgM, IgG, IgA, Prealbumin, Antithrombin III, AAT, Albumin, C4, C3, alpha-2-Macroglobulin, Alpha-1-Acid Glycoprotein, Ceruloplasmin, Transferrin, Haptoglobin, and Beta-2-Microglobulin) on the Beckman Immage 800 analyzer.

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™ Protein Linearity Set (k101216)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

A. 510(k) Number:
k112705

B. Purpose for Submission:
New device

C. Measurand:
Quality control material for Immunoglobulin E (IgE), Immunoglobulin M (IgM), Immunoglobulin G (IgG), Immunoglobulin A (IgA), Prealbumin, Antithrombin III, Alpha-1-antitrypsin (AAT), Albumin, Complement C4 (C4), complement C3 (C3), Alpha-2-macroglobulin, Alpha-1-acid glycoprotein, Ceruloplasmin, Transferrin, Haptoglobin, and Beta-2-microglobulin

D. Type of Test:
Quality control material

E. Applicant:
Aalto Scientific Ltd.

F. Proprietary and Established Names:
Audit® MicroLQ™ Serum Protein Control

G. Regulatory Information:
1. Regulation section:
21 CFR §862.1660, Quality control material (assayed and unassayed)
2. Classification:
Class I
3. Product code:
JJY, Multi-analyte controls, all kinds (assayed)
4. Panel:
Clinical Chemistry (75)

H. Intended Use:
1. Intended use(s):
Audit® MicroLQ™ Serum Protein Control is an assayed, ready-to-use liquid, bi-level human serum-based control for use with assays designed to quantitate: Immunoglobulin E (IgE), Immunoglobulin M (IgM), Immunoglobulin G (IgG), Immunoglobulin A (IgA), Prealbumin, Antithrombin III, Alpha-1-Antitrypsin (AAT), Albumin, Complement C4 (C4), Complement C3 (C3), alpha-2-Macroglobulin, Alpha-1-Acid Glycoprotein, Ceruloplasmin, Transferrin, Haptoglobin, and Beta-2-Microglobulin. It is intended to simulate human patient samples for the purpose of monitoring the precision of laboratory testing procedures for Immunoglobulin E (IgE), Immunoglobulin M (IgM), Immunoglobulin G (IgG), Immunoglobulin A (IgA), Prealbumin, Antithrombin III, Alpha-1-Antitrypsin (AAT), Albumin, Complement C4 (C4), Complement C3 (C3), alpha-2-Macroglobulin, Alpha-1-Acid Glycoprotein, Ceruloplasmin, Transferrin, Haptoglobin, and Beta-2-Microglobulin assays. 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 product is intended for use with quantitative assays on Beckman Image 800.

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The Audit® MicroLQ™ Serum Protein Control is for In Vitro Diagnostic use only.

2. Indication(s) for use:
Same as Intended Use

3. Special conditions for use statement(s):
None

4. Special instrument requirements:
Performance was established on the Beckman Immage 800 analyzer.

I. Device Description:
The Audit® MicroLQ™ Serum Protein Control is a human serum-based protein control mixture. The base matrix is human serum. This is the starting matrix for building the two sets of controls: Low (Level 1) and High (Level 2) Controls. Both sets of controls contain the following analytes: Immunoglobulin E (IgE), Immunoglobulin M (IgM), Immunoglobulin G (IgG), Immunoglobulin A (IgA), Prealbumin, Antithrombin III, Alpha-1-Antitrypsin (AAT), Albumin, Complement C4 (C4), Complement C3 (C3), alpha-2-Macroglobulin, Alpha-1-Acid Glycoprotein, Ceruloplasmin, Transferrin, Haptoglobin, and Beta-2-Microglobulin. The Level 1 set contains lower levels of each analyte (except for beta-2-microglobulin) and the Level 2 set contains higher levels of each analyte.

The product is kitted as bi-level control with three 2-mL vials for each level, for a total of 6 vials.

J. Substantial Equivalence Information:

1. Predicate device name(s) and 510(k) number(s):
Audit® MicroCV™ Protein Linearity Set, k101216

2. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | Assayed QC material | Same |
| Analytes | Includes Alpha-1-antitrypsin, Complement C3, Complement C4, Immunoglobulin G, Immunoglobulin M, Immunoglobulin A, Transferrin | Same |
| Matrix | Human serum-based | Same |
| Storage | 2-8°C | Same |
| Form | Liquid | Same |

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| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Analytes | Includes Immunoglobulin E, Prealbumin, Antithrombin III, Albumin, Alpha-2-Macroglobulin, Alpha-1-Acid Glycoprotein, Ceruloplasmin, Haptoglobulin, and Beta-2-Microglobulin | These analytes are not included |
| | | |
| Type of Control | Bi-level control | Linearity set (5 levels) |

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

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
The analytes used in this control material are human derived materials obtained from commercial vendors and QC tested in-house.
Value assignment
Each analyte value assignment for Level 1 and Level 2 was performed on the Beckman Immage 800 analyzer. All 16 analytes have been cleared for use with the Beckman Immage analyzer. Each analyte was measured 15 times (over a three-day period) and the mean value of each analyte was used to establish target concentration values at each level. The target ranges were calculated as $\pm 15\%$ of the target value. Expected value ranges for Level 1 and Level 2 of each analyte are shown in the table below. There is no Level 1 value for Beta-2-Microglobulin.

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| Assay/Reagent | Units | Level 1 | | Level 2 | |
| --- | --- | --- | --- | --- | --- |
| | | Mean | Range | Mean | Range |
| Immunoglobulin E | IU/mL | 231 | 196-265 | 573 | 487-659 |
| Immunoglobulin M | mg/dL | 106 | 90-122 | 328 | 279-377 |
| Immunoglobulin G | mg/dL | 744 | 633-856 | 2081 | 1769-2394 |
| Immunoglobulin A | mg/dL | 267 | 227-307 | 644 | 547-740 |
| Prealbumin | mg/dL | 24.5 | 20.8-28.2 | 60.0 | 51.0-69.0 |
| Antithrombin III | mg/dL | 20.2 | 17.2-23.2 | 52.0 | 44.2-59.8 |
| Alpha-1-Antitrypsin | mg/dL | 97.5 | 82.9-112.2 | 250 | 212-287 |
| Albumin | mg/dL | 2377 | 2021-2734 | 6617 | 5625-7610 |
| Complement C4 | mg/dL | 19.9 | 16.9-22.9 | 55.3 | 47.0-63.6 |
| Complement C3 | mg/dL | 66.7 | 56.7-76.7 | 197 | 167-227 |
| alpha-2-Macroglobulin | mg/dL | 89.2 | 75.8-102.6 | 274 | 233-315 |
| Alpha-1-Acid Glycoprotein | mg/dL | 53.5 | 45.5-61.5 | 160 | 136-184 |
| Ceruloplasmin | mg/dL | 25.2 | 21.4-29.0 | 68.2 | 58.0-78.5 |
| Transferrin | mg/dL | 176 | 149-203 | 506 | 430-582 |
| Haptoglobin | mg/dL | 103 | 87-117 | 284 | 241-327 |
| Beta-2-Microglobulin | mg/L | N/A | N/A | 0.955 | 0.812-1.099 |

## Stability

A stability/shelf-life claim of 3 years at $2 - 8^{\circ}\mathrm{C}$ was determined based on an accelerated stability study on two lots of material. All vials that were used for stressed stability studies were first stressed in the incubator for 30 days, after which time the vials were opened, left at room temperature for 15 minutes, closed and left for 30 minutes at $2 - 8^{\circ}\mathrm{C}$. The percent loss was determined in comparison to Day Zero values and the product is considered stable when the loss reported is $\leq 15\%$ loss. Confirmatory real-time stability tests are ongoing.

There is no specific claim in the product labeling for on-board vial stability. After opening, the contents should be used according to the instrument manufacturer's instructions and immediately returned to $2 - 8^{\circ}\mathrm{C}$. The control material should not be left in the instrument and should be recapped and returned to the refrigerator after each use.

d. Detection limit:
Not applicable

e. Analytical specificity:
Not applicable

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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 and Specificity:
Not applicable
b. Other clinical supportive data (when a. and b. are not applicable):
Not applicable

4. Clinical cut-off:
Not applicable

5. Expected values/Reference range:
Reference ranges for each analyte are supported by the scientific literature.
Expected values are provided in the labeling for each 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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