RANDOX IMMUNOASSAY CONTROL

K040379 · Randox Laboratories, Ltd. · JJY · Jun 16, 2004 · Clinical Chemistry

Device Facts

• Record ID: K040379
• Device Name: RANDOX IMMUNOASSAY CONTROL
• Applicant: Randox Laboratories, Ltd.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Jun 16, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

This product is intended for in vitro diagnostic use in the quality control of Immunoassays on clinical chemistry and Immunoassay systems.

Device Story

Randox Immunoassay Controls are lyophilized human serum-based materials provided at three constituent concentrations (Levels I, II, and III). Used in clinical laboratories to monitor the accuracy and precision of immunoassay and clinical chemistry systems. The product is reconstituted with distilled water before use. It contains 33 analytes, including hormones, tumor markers, and therapeutic drugs. Laboratory personnel use the controls to verify system performance; results are compared against assigned target values and ranges provided in the package insert. The device serves as a standard reference material to ensure diagnostic test reliability.

Clinical Evidence

No clinical data; bench testing only. Device is a quality control material used to verify analytical performance of immunoassay systems.

Technological Characteristics

Lyophilized human serum-based control material. Supplied in 5 ml vials for reconstitution with distilled water. Contains 33 analytes (e.g., AFP, PSA, TSH, Digoxin). Stability: 7 days at 2-8°C (reconstituted) or 4 weeks at -20°C. PSA stability: 2 days at 2-8°C. No electronic or software components.

Indications for Use

Indicated for use as quality control material for monitoring accuracy and precision in immunoassay laboratory testing. Intended for use by qualified laboratory personnel in clinical laboratory settings.

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: k040379

B. Purpose For Submission:

Premarket Notification 510(k) of intention to manufacture and market the Randox Laboratories Ltd. Immunoassay Control, Levels I, II, III.

C. Analyte: Thirty-three different analytes listed in J (3) below.

D. Type of Test: Quality Control Material

E. Applicant: Randox Laboratories Ltd.

F. Proprietary and Established Names: Randox Immunoassay Control Levels I, II and III

G. Regulatory Information:

1. Regulation section: 21 CFR §862.1660, Multi-Analyte Controls, all kinds (assayed and unassayed).
2. Classification: Class I
3. Product Code: JJY
4. Panel: 75 Chemistry

H. Intended Use:

1. Intended use(s):

This product is intended for in vitro diagnostic use in the quality control of Immunoassays on clinical chemistry and Immunoassay systems.

2. Indication(s) for use:

The Randox Laboratories Ltd. Immunoassay Controls (Levels I, II, and III) are based on lyophilized human serum and have been developed for the control of both accuracy and precision in clinical chemistry applications, particularly Immunoassay analysis. The control materials are available at three constituent concentrations. Each level is available in a 5 ml final re-constituted volume.

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The Randox Assayed Immunoassay Controls should only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.

3. Special condition for use statement(s):
Prescription use

4. Special instrument Requirements:
The names of the specific analyzers are listed in the package insert.

I. Device Description:

The Randox Immunoassay Controls are human based lyophilized sera which are supplied at levels I, II and III. Each 5 ml vial of lyophilized serum is reconstituted with exactly 5 ml of distilled water at +20 to 25° C. This material is inherently free from human based infective sources of human immunodeficiency Virus (HIV 1, HIV 2) antibody, hepatitis B surface antigen, and hepatitis C virus antibody. Nevertheless it should be handled and disposed of with the same attention afforded to human samples.

J. Substantial Equivalence Information:

1. Predicate device name(s):
Bio-Rad Immunoassay Control Serum

2. Predicate K number(s):
k894252

3. Comparison with Predicate:
The Randox Immunoassay Controls are equivalent to the Bio Rad Lyphochek® Immunoassay Plus Control, Levels 1, 2, and 3 previously cleared under (k894252). The table below lists the similarities and differences between the Predicate and Proposed device.

| Characteristic | Proposed Device: Randox Immunoassay Control, Level I, II, and III (k040379) | Predicate Device Bio-Rad Lypochek® Immunoassay Plus Control, Levels 1, 2, and 3 (k894252) |
| --- | --- | --- |
| Intended Use | This product is intended for in vitro diagnostic use in the quality control of Immunoassays on clinical chemistry and Immunoassay systems. | Similar |
| Matrix | Lyophilized human sera with added constituents. | Similar |
| Number Of Levels | Levels I, II, and III | Similar |
| Open Vial Stability | Reconstituted serum is stable | Similar |

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| | for 7 days at 2 to 8°C if kept capped in original container and free from contamination or 4 weeks frozen once at -20°C. The P.S.A. in these sera will be stable for 2 days at +2 to +8°C. | |
| --- | --- | --- |
| Unopened Vial Stability | Unopened vials stored at 2 to 8°C are stable through the expiration dated printed on the individual vials. | Similar |
| Product Description | The Randox Laboratories Ltd. Immunoassay Controls (Levels I, II, and III) are based on lyophilized human serum and have been developed for the control of both accuracy and precision in clinical chemistry applications, particularly Immunoassay analysis. The control materials are available at three constituent concentrations. Each level is available in a 5 ml final re-constituted volume. | Similar |
| Precautions | Is intended for in vitro diagnostic use only by trained personnel. This material is inherently free from human based infective sources. Nevertheless it should be handled and disposed of with the same attention afforded to human samples. | Similar |
| Parameters | Contains the following 33 Analytes: AFP, B2M, CA125, CA15-3, CA19-9, CARBAMAZEPINE, CEA, CORTISOL, DHEA-S, DIGOXIN, FERRITIN, FOLATE, FSH, GROWTH HORMONE, HCG, IGE, LH, ESTRADIOL, PHENYTOIN, 17-OH-PROGESTERONE, | Similar |

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| | PROGESTERONE,
PROLACTIN, PSA FREE,
PSA TOTAL, FREE T3,
TOTAL T3, FREE T4,
TOTAL T4,
TESTOSTERONE,
THEOPHYLLINE, TSH,
VALPROIC ACID, VITAMIN
B12 | |
| --- | --- | --- |

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

FDA guidance “Points to Consider Guidance Document on Assayed and Unassayed Quality Control Materials”.

L. Test Principle: NA

M. Performance Characteristics (if/when applicable):

1. Analytical performance:
a. Precision/Reproducibility: NA
b. Linearity/assay reportable range: NA
c. Traceability (controls, calibrators, or method):

Each batch of Immunoassay control is submitted to a number of reference Laboratories and values are assigned from a consensus of results obtained by these laboratories. A value (Mean) has been assigned to this lot of control at Randox Laboratories Ltd using an ELISA method. The package insert lists the target values and ranges applicable to each analyte and each instrument.

Reconstituted serum is stable for 7 days at 2 to 8°C if kept capped in original container and free from contamination or 4 weeks frozen once at -20°C. Only the required amount of product should be removed. After use, any residual product should NOT BE RETURNED to the original vial. The PSA will remain stable for 2 days at +2 to +8°C.

d. Detection limit: NA
e. Analytical specificity: NA
f. Assay cut-off: NA

2. Comparison studies:
a. Method comparison with predicate device: NA

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b. Matrix comparison: NA

3. Clinical studies:
a. Clinical sensitivity: NA
b. Clinical specificity: NA
c. Other clinical supportive data (when a and b are not applicable): NA

4. Clinical cut-off: NA

5. Expected values/Reference range: NA

N. Conclusion:

The submitted material in this premarket notification is complete and supports a substantial equivalence decision.