RANDOX MATERNAL CONTROL, LEVELS 1, 2 AND 3

K113720 · Randox Laboratories, Ltd. · JJY · Sep 20, 2012 · Clinical Chemistry

Device Facts

• Record ID: K113720
• Device Name: RANDOX MATERNAL CONTROL, LEVELS 1, 2 AND 3
• Applicant: Randox Laboratories, Ltd.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Sep 20, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The Randox Maternal Controls Level 1, Level 2 and Level 3 are intended for in vitro diagnostic use in the quality control of Unconjugtaed Estriol and Total ß-Human Chorionic Gonadotrophin methods on clinical chemistry systems. This in vitro diagnostic device is intended for prescription use only.

Device Story

Randox Maternal Controls are multi-analyte quality control materials provided in three levels (Level 1, 2, 3) to monitor clinical chemistry assay performance. Derived from human serum, the controls contain Unconjugated Estriol and Total β-Human Chorionic Gonadotrophin (Beta hCG). The product is supplied in a lyophilized format requiring reconstitution. Used in routine hospital laboratories, the controls are processed on clinical chemistry analyzers alongside patient samples. Healthcare providers compare the analyzer's measured values for the controls against target ranges provided in lot-specific inserts to verify assay accuracy and precision. This monitoring ensures the reliability of maternal screening test results, aiding in clinical decision-making.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, specifically accelerated stress testing to establish shelf-life stability. Stability was confirmed by comparing recovery of controls stored at 37°C against those stored at 2-8°C, with a passing criterion of <10% deviation.

Technological Characteristics

Lyophilized human serum-based multianalyte controls. Provided in three levels to span clinically significant decision ranges. Designed for use on clinical chemistry systems. Stability established via accelerated stress testing at 37°C.

Indications for Use

Indicated for quality control of Unconjugated Estriol and Total ß-Human Chorionic Gonadotrophin assays on clinical chemistry systems. Intended for prescription use in 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.

Predicate Devices

• Bio-Rad Lyphochek Maternal Serum Controls Levels 1, 2 and 3

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE

A. 510(k) Number:
k113720

B. Purpose for Submission:
New device

C. Measurand:
Multi-analyte control materials

D. Type of Test:
Not applicable

E. Applicant:
Randox Laboratories Limited

F. Proprietary and Established Names:
Randox Maternal Controls Level 1, Level 2 and Level 3

G. Regulatory Information:

| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| JJY – Quality Control Material (Assayed and Unassayed) | Class I, reserved | 862.1660 | Clinical Chemistry |

H. Intended Use:

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

2. Indication(s) for use:

{1}

The Randox Maternal Controls Level 1, Level 2 and Level 3 are intended for in vitro diagnostic use in the quality control of Unconjugated Estriol and Total $\beta$ -Human Chorionic Gonadotrophin methods on clinical chemistry systems.

3. Special conditions for use statement(s):

For in vitro diagnostic use

For prescription use only

4. Special instrument requirements:

Values are listed in the package insert for several analyzers

# I. Device Description:

Randox Maternal Controls are manufactured at three levels, Level 1, Level 2 and Level 3. The analyte concentrations in each of the three levels have been chosen to span a range that includes the chemically significant or medical decision level(s) for each analyte (Free Estriol and Total $\beta$ -Human Chorionic Gonadotrophin [Beta hCG]). The analyte concentrations are clinically relevant for use in routine hospital laboratories.

Human source material from which this product has been derived and has been tested at the donor level for the Human Immunodeficiency Virus (HIV1 &amp; HIV2) antibody, Hepatitis B surface antigen (HbsAg) and the Hepatitis C virus (HCV) antibody and were found to be non-reactive based on FDA approved methods.

# J. Substantial Equivalence Information:

1. Predicate device name(s):

Bio-Rad Lyphochek Maternal Serum Controls

2. Predicate $510(\mathrm{k})$ number(s):

k984594

3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| | Randox Maternal Controls | Bio-Rad Lyphochek Maternal Serum Control (k984594) |
| Intended Use | The Randox Maternal | Same |

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| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| | Controls Level 1, Level 2 and Level 3 are intended for in vitro diagnostic use in the quality control of Unconjugated Estriol and Total β-Human Chorionic Gonadotrophin | |
| Size | 1 ml | 5 ml |
| Format | Lyophilized | Same |
| Matrix | Human serum | Same |
| Storage (unopened) | +2 - +8 °C
Until expiration date | Same |
| Open vial claim | 7 days at +2 - +8 °C | 10 days at +2 - +8 °C |
| Analytes | Unconjugated Estriol, and Total β-Human Chorionic Gonadotrophin | Same, but with Alphafoetoprotein |
| Number of Levels | 3 | Same |

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

Not applicable

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

{3}

The analytes contained in the Randox Maternal Controls were obtained from commercially available standards.

## Stability

Stability protocols and acceptance criteria were reviewed and found acceptable. Closed vial (shelf-life) stability at the recommended storage temperature of (2 to 8 °C) was demonstrated based on accelerated stability. Closed vials are stable until the date printed on individual vials. Real-time closed vial stability studies are on-going. For open-vial stability, the sponsor demonstrated that reconstituted serum is stable for 7 days at the recommended storage temperature of 2 to 8°C. All storage recommendations are provided in the labeling.

## Value Assignment

Value assignment was determined for each analyte contained in the Randox Maternal Controls using multiple analyzer platforms and replicate analysis of samples by external clinical laboratories and internal testing conducted at Randox Laboratories Ltd.

Value assignment data were collated and an appropriate target value was assigned to each analyte based on the average of the observed values. Ranges were then assigned depending on the analyte. The labeling states that obtained values should fall within the specified range provided on lot-specific value sheets and that laboratories should establish appropriate acceptance criteria when using this product for its intended use.

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

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b. Matrix comparison:
Not applicable

3. Clinical studies:
a. Clinical Sensitivity:
Not applicable
b. Clinical specificity:
Not applicable
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:
Target and range values for representative analyzers are found in the package insert for each specific lot.

N. Proposed Labeling:
All 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.