RANDOX LIQUID IMMUNOASSAY PREMIUM CONTROLS, LEVEL 1, LEVEL2, LEVEL 3 AND TRI LEVEL

K112337 · Randox Laboratories, Ltd. · JJY · Dec 1, 2011 · Clinical Chemistry

Device Facts

• Record ID: K112337
• Device Name: RANDOX LIQUID IMMUNOASSAY PREMIUM CONTROLS, LEVEL 1, LEVEL2, LEVEL 3 AND TRI LEVEL
• Applicant: Randox Laboratories, Ltd.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Dec 1, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The Randox Liquid Immunoassay Premium Controls, Level 1, Level 2, Level 3 and Tri Level are liquid controls developed for use in the quality control of quantitative assays stated in the package insert.

Device Story

Randox Liquid Immunoassay Premium Controls are ready-to-use, human serum-derived liquid controls. They contain a panel of analytes including hormones, therapeutic drugs, and tumor markers. Used in clinical laboratories to monitor the performance of quantitative immunoassay systems; they provide a consensus-based control range (mean ± 2 SD) for specific instruments. Healthcare providers use these controls to verify assay accuracy and precision; results outside the expected range indicate potential system error, prompting investigation before patient sample testing. Benefits include ensuring reliable diagnostic results for patient management.

Clinical Evidence

No clinical data. Bench testing only. Stability studies were conducted to validate the 12-month shelf life at -20 to -70°C, 30-day stability for thawed unopened vials at 2-8°C, and 7-day stability for opened vials at 2-8°C.

Technological Characteristics

Human serum-derived liquid control material. Analyte panel includes hormones, therapeutic drugs, and tumor markers. Value assignment via consensus of reference laboratories using multiple instrument platforms. Storage: -20 to -70°C (unopened).

Indications for Use

Indicated for use as quality control material for quantitative immunoassays in clinical laboratory settings. For prescription use.

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

• Bio-Rad Liquichek Immunoassay Plus Controls Levels 1, 2 and 3

Submission Summary (Full Text)

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

A. 510(k) Number:
k112337

B. Purpose for Submission:
New Device

C. Measurand:
Serum quality control materials containing the following analytes: 17-OH-progesterone, Aldosterone, Alpha fetoprotein, Amikacin, Carbamazepine, Carcinoembryonic Antigen (CEA), Cortisol, DHEA-S, Digoxin, Ethosuximide, Ferritin, Folate, Free T3, Free T4, FSH, Gentamicin, Growth Hormone (GH), Immunoglobulin E, Insulin, Luteinizing Hormone (LH), Estradiol, Acetaminophen, Phenytoin, Primidone, Progesterone, Prolactin, PSA Free, PSA Total, Salicylic Acid, SHBG, T Uptake, Testosterone, Theophylline, Thyroid Stimulating Hormone, Tobramycin, Total Beta hCG, Total T3, Total T4, Valproic Acid, Vancomycin and Vitamin B12.

D. Type of Test:
Not Applicable.

E. Applicant:
Randox Laboratories LTD.

F. Proprietary and Established Names:
Randox Liquid Immunoassay Premium Controls, Level 1, level 2, Level 3 and Tri Level

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

H. Intended Use:
1. Intended use(s):
Please see indications for use below.

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2. **Indication(s) for use:**
The Randox Liquid Immunoassay Premium Controls, Level 1, Level 2, Level 3 and Tri Level are liquid controls developed for use in the quality control of quantitative assays stated in the package insert.

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

4. **Special instrument requirements:**
Performance was evaluated on the following instrument systems: Abbott Architect, Abbott AXSYM, Roche Cobas 6000, Roche Modular E170, Roche Elecsys, Roche Cobas E411, Roche Integra, bioMerieux Vidas, Siemens Immulite 1000, Siemens Immulite 1000 1st generation, Siemens Immulite 2000/2500, Siemens Advia Centaur, Beckman Access, Beckman Dxl800, Beckman Access, Vitros ECi and Vitros, Tosoh (model A1A360), Diasorin Liaison.

I. **Device Description:**
The Randox Liquid Immunoassay Premium Controls are ready to use, liquid controls derived from human based serum. The Human based serum from which this product is derived has been tested by FDA approved methods at donor level for the Human Immunodeficiency Virus (HIV 1, HIV 2) antibody, Hepatitis B Surface Antigen (HbsAg) and Hepatitis C Virus (HCV) antibody and found to be non-reactive. Each control level is purchased separately or as a kit (Tri Level) and is packaged in 12 x 5ml bottles.

J. **Substantial Equivalence Information:**

1. **Predicate device name(s):**
Bio-Rad Liquichek Immunoassay Plus Controls Level 1, 2 and 3.

2. **Predicate 510(k) number(s):**
k001373

3. **Comparison with predicate:**

| Characteristics | Randox Liquid Immunoassay Premium Controls, Level 1, level 2, Level 3 and Tri Level (Candidate Device) | Bio-Rad Liquichek Immunoassay Plus Controls Level 1, 2 and 3 (Predicate - k001373) |
| --- | --- | --- |
| Indication for use / Intended for Use | The Randox Liquid Immunoassay Premium Controls, Level 1, Level 2, Level 3 and Tri Level are liquid controls developed for use in the quality control of quantitative assays stated in the package insert. | Same |
| Test System (Instrumentation / | Abbott Architect, Abbott AXSYM, Roche Cobas 6000, Roche Modular E170, Roche Elecsys, Roche Cobas E411, Roche | Same |

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| technology) | Integra, bioMerieux Vidas, Siemens Immulite 1000, Siemens Immulite 1000 1st generation, Siemens Immulite 2000/2500, Siemens Advia Centaur, Beckman Access, Beckman Dxl800, Beckman Access, Vitros ECi and Vitros, Tosoh (model A1A360), Diasorin Liaison. | |
| --- | --- | --- |
| Analyte | 17-OH-progesterone, Aldosterone, Alpha fetoprotein, Amikacin, Carbamazepine, Carcinoembryonic Antigen (CEA), Cortisol, DHEA-S, Digoxin, Ethosuximide, Ferritin, Folate, Free T3, Free T4, FSH, Gentamicin, Growth Hormone (GH), Immunoglobulin E, Insulin, Luteinizing Hormone (LH), Estradiol, Acetaminophen, Phenytoin, Primidone, Progesterone, Prolactin, PSA Free, PSA Total, Salicylic Acid, SHBG, T Uptake, Testosterone, Theophylline, Thyroid Stimulating Hormone, Tobramycin, Total Beta hCG, Total T3, Total T4, Valproic Acid, Vancomycin and Vitamin B12. | Same |
| Stability claim / Storage Temperature Thaw | Opened: 7 days @ 2-8°C
Unopened: 30 days @ 2-8°C | Opened: 14 days when stored at 2-8°C, with the exception of: Folate 4 days and Estradiol 5 days.
Unopened: 30 days with exception of Folate 4 days, Estradiol 8 days, Free PSA, PSA and Prolactin 14 days. |
| Shelf life | 12 months @ -20 to - 70 | 28 months @ -20 |

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 and Value Assignment
Control solutions are derived from gravimetrically prepared stock solutions and analyzed in-house. Each lot of Liquid Immunoassay Premium is submitted to a number of reference laboratories using multiple instruments and values are assigned

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from a consensus of the results obtained by these laboratories. With each lot a control range is provided for each analyte and instrument. The control range is equivalent to the mean $\pm 2$ SD. Assigned control ranges are listed in the labeling by instrument and analyte.

## Stability

Real time stability study protocols and acceptance criteria were described and found to be acceptable.

The stability claim for the controls is 12 months at -20 to $-70^{\circ}\mathrm{C}$ for unopened vials. Thawed unopened vials stability claim is 30 days when stored at $2-8^{\circ}\mathrm{C}$. Thaw stability claim for opened vials is 7 days when stored at $2-8^{\circ}\mathrm{C}$.

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.

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:
Expected values and control ranges are provided in the package insert.

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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