RANDOX SPECIALITY CONTROL (I) LEVELS 1, 2 AND 3

K130337 · Randox Laboratories Limited · JJY · Jun 19, 2013 · Clinical Chemistry

Device Facts

• Record ID: K130337
• Device Name: RANDOX SPECIALITY CONTROL (I) LEVELS 1, 2 AND 3
• Applicant: Randox Laboratories Limited
• Product Code: JJY · Clinical Chemistry
• Decision Date: Jun 19, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The Randox Immunoassay Speciality Control (I) Levels 1, 2 and 3 are intended for in vitro diagnostic use as assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. This device is for prescription use only.

Device Story

Randox Immunoassay Speciality Control (I) consists of three levels of lyophilized human serum-based control material; contains added human-derived constituents, chemicals, stabilizers, and preservatives. Used in clinical laboratories to monitor precision of testing procedures for specific analytes (e.g., Vitamin D, thyroid antibodies, hormones). Requires reconstitution with distilled water before use. Healthcare professionals (laboratory technicians/scientists) use the control alongside patient samples; results are compared against assigned ranges to verify instrument/reagent performance. Discrepancies in control values alert the laboratory to potential errors in testing, ensuring the accuracy and reliability of patient diagnostic results.

Clinical Evidence

No clinical data. Bench testing only. Stability studies were conducted to determine shelf life and open-vial stability for various analytes under refrigerated and frozen conditions. Value assignment was performed via consensus of results from multiple reference laboratories using statistical analysis.

Technological Characteristics

Lyophilized human serum-based control material. Requires reconstitution with distilled water. Analyte concentrations span medical decision levels. Stability: 2 years shelf life; open-vial stability varies by analyte (1-5 days refrigerated); frozen stability 4 weeks at -20°C. No electronic components or software algorithms.

Indications for Use

Indicated for use as assayed quality control material to monitor precision of laboratory testing procedures for specified analytes in human serum. For in vitro diagnostic and prescription use only.

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

• Biorad Liquichek™ Speciality Immunoassay Control LTA Levels 1, 2 and 3 (k043108)

Submission Summary (Full Text)

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

A. 510(k) Number:
k130337

B. Purpose for Submission:
New device

C. Measurand:
Multi-analyte control materials: 1-25 hydroxy-Vitamin D [1-25 (OH)² Vitamin D], 25 hydroxy-Vitamin D (25-OH-vitamin D), anti-Thyroglobulin (anti-TG), anti-Thyroid Peroxidase (anti-TPO), C-peptide of Proinsulin (C-peptide), Insulin Like Growth Factor (IGF-1), Parathyroid hormone (PTH), Procalcitonin, and Insulin

D. Type of Test:
Not applicable

E. Applicant:
Randox Laboratories Limited

F. Proprietary and Established Names:
Randox Immunoassay Speciality Control (I) Levels 1, 2 and 3

G. Regulatory Information:
1. Regulation section:
21 CFR 862.1660, Quality control material (assayed and unassayed)
2. Classification:
Class I, reserved
3. Product code:
JJY

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4. Panel:

Clinical Chemistry (75)

H. Intended Use:

1. Intended use(s):

The Randox Immunoassay Speciality Control (I) Levels 1, 2 and 3 are intended for in vitro diagnostic use as assayed quality control material to monitor the precision of laboratory testing procedures for 1-25 Dihydroxy Vitamin D (1-25 (OH)² Vitamin D), 25 Hydroxy Vitamin D (25-OH Vitamin D), anti-Thyroglobulin (anti-TG), anti-Thyroid Peroxidase (anti-TPO), C-Peptide, Insulin Like Growth Factor (IGF-1), Parathyroid Hormone (PTH), Procalcitonin and Insulin.

2. Indication(s) for use:

Same as intended use.

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 labeling for several analyzers. Values were assigned on these analyzers. Representative analyzer specific values are shown in below.

I. Device Description:

Randox Immunoassay Speciality Control (I) is manufactured at three levels, Level 1, Level 2 and Level 3, for each analyte. Individual analyte values listed in the package insert are specific for the instrument system utilized.

Each control is prepared from human serum with added constituents of human origin, chemicals, stabilizers and preservatives. They are supplied in lyophilized form in 5×2ml vials and require reconstitution with 2ml of distilled water.

The individual analyte concentrations in each of the three levels have been chosen to span a range that includes the chemically significant or medical decision levels.

Human source material from which this product has been derived has been tested at the donor level for the Human Immunodeficiency Virus (HIV-1 & HIV-2) 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.

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J. Substantial Equivalence Information:

1. Predicate device name(s):

Biorad Liquichek™ Speciality Immunoassay Control LTA Levels 1, 2 and 3

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

k043108

3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | The Randox Immunoassay Speciality Control (I), Levels 1, 2 & 3 are intended for in vitro diagnostic use as assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. | For use as a quality control serum to monitor the precision of laboratory testing procedures listed in the package insert |
| Matrix | Human Serum | same |
| Differences | | |
| --- | --- | --- |
| Size | 2 ml | 5 ml |
| Format | Lyophilized | Liquid |
| Storage (Unopened) | 2 to 8°C
Until expiration date | -20 to -70°C
Until expiration date |
| Analytes: | | |
| 1-25 (OH)2 Vitamin D | Present | Not present |
| 25-OH Vitamin D | Present | Present |
| anti-TG | Present | Present |
| anti-TPO | Present | Present |
| C-peptide | Present | Present |
| IGF-1 | Present | Present |
| PTH | Present | Intact PTH |
| Procalcitonin | Present | Not present |
| Insulin | Present | Not present |
| Osteocalcin | Not present | Present |
| Open Vial Stability | Store refrigerated +2 to 8°C
Insulin, Anti-TPO 1-25 (OH)2 Vitamin D and 25 OH Vitamin D are stable for 5 | Once the product is thawed and opened, all analytes will be stable for 30days when stored tightly capped at 2-8°C with the exception of PTH which will be |

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| Differences | | |
| --- | --- | --- |
| | days at +2°C to +8°C if kept capped in original container and free from contamination. Anti-TG is stable for 3 days at +2°C to +8°C.
C-Peptide, IGF-1 and Procalcitonin are stable for 1 day at +2°C to +8°C.
The Immunoassay Speciality Control (I) is stable for 4 weeks frozen once at -20°C.
Parathyroid hormone (PTH) should be tested within 4 hours of reconstitution when stored at +2°C to +8°C, or within 2 weeks when stored below -20°C. | stable for 23 days.
PTH, Anti-TG and Anti TPO will be stable for 30 days when stored in tightly capped aliquot vials at -20°C to -70°C. |
| Shipping Temperature | +2 to 8°C | -20 to -70°C |

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

None were 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 contained in the Randox Speciality Immunoassay Control (I) Levels 1, 2 and 3 were obtained from commercially available sources. Not traceable to WHO

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standards.

# Value Assignment:

Each batch of Immunoassay Speciality (I) Control is submitted to a number of external laboratories and values were assigned from a consensus of results obtained. Each batch has lot-specific target values for each analyte. A range of $\pm 25\%$ is provided for individual analytes and each analyzer method. The sponsor recommends that the range provided should only be considered as a reference and that each laboratory establishes its own ranges.

Table 1: Immunoassay Speciality (I) Control values

| Analyte | Analyzer | Units | Level 1 | Level 2 | Level 3 |
| --- | --- | --- | --- | --- | --- |
| 1-25 OH Vitamin D | IDS RIA | pmol/l | 34.2 | 121.0 | 203.0 |
| 25 OH Vitamin D | Roche Elecsys | nmol/l | N/A | 96.8 | 116.0 |
| | Roche Cobas E411 | nmol/l | 60.5 | N/A | 108.0 |
| | Diasorin Liaison | nmol/l | 46.9 | 76.7 | 108.0 |
| | IDS ELISA | nmol/l | 63.5 | 107 | N/A |
| | Abbott Architect | nmol/l | N/A | 65.3 | 83.7 |
| | Ortho Vitros ECi/ECiQ/3600/5600 | nmol/l | 58.4 | 87.4 | 105.6 |
| Anti TG | Siemens Immulite 2000/2500 | IU/ml | 33.1 | 127 | 230.0 |
| | Abbott Architect | IU/ml | 28.0 | 72.6 | 100.0 |
| | Abbott AXSYM | IU/ml | 53.2 | 185.0 | 315.0 |
| | Roche Cobas E411 | IU/ml | 175.0 | 633.0 | 801.0 |
| | Roche Elecsys | IU/ml | 157.0 | 622.0 | 761.0 |
| | Roche Cobas 6000/8000 | IU/ml | 164.0 | 551.0 | 704.0 |
| | Roche Modular E170 | IU/ml | N/A | N/A | 705.0 |
| | Siemens Advia Centaur | IU/ml | 135.0 | 624.0 | N/A |
| Anti TPO | Roche Modular E170 | IU/ml | 13.1 | 103.0 | 188.0 |
| | Abbott Architect | IU/ml | 31.2 | 101.0 | 160.0 |
| | Abbott AXSYM | IU/ml | N/A | N/A | 116.0 |
| | Siemens Immulite 1000 | IU/ml | 33.6 | N/A | N/A |
| | Siemens Immulite 2000/2500 | IU/ml | 33.2 | 113.0 | 170.0 |
| | Roche Cobas E411 | IU/ml | 15.3 | 105.0 | 201.0 |
| | Roche Cobas 6000/8000 | IU/ml | N/A | 102.0 | 189.0 |
| | Roche Elecsys | IU/ml | 14.7 | 101.0 | 203.0 |
| | Beckman DxI 600/800 | IU/ml | 26.2 | 85.5 | 142.0 |

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| Analyte | Analyzer | Units | Level 1 | Level 2 | Level 3 |
| --- | --- | --- | --- | --- | --- |
| | Siemens Advia Centaur | IU/ml | 182.0 | 365.0 | 476.0 |
| C-Peptide | Tosoh A II 600 | ng/ml | 1.71 | N/A | N/A |
| | Siemens Advia Centaur | ng/ml | 1.19 | 2.60 | 4.35 |
| | Roche Cobas 6000/8000 | ng/ml | 1.58 | 3.02 | 5.31 |
| | Roche Elecsys | ng/ml | 1.54 | N/A | N/A |
| | Siemens Immulite 1000 | ng/ml | 1.02 | 2.35 | 4.71 |
| | Abbott Architect | ng/ml | 1.17 | N/A | N/A |
| | Siemens Immulite 2000/2500 | ng/ml | 1.06 | 2.35 | 4.71 |
| | Roche Modular E170 | ng/ml | 1.50 | 2.90 | 5.10 |
| | Roche Cobas E411 | ng/ml | 1.52 | 2.93 | 5.28 |
| IGF 1 | Siemens Immulite 2000/2500 | ng/ml | 44.0 | 287.0 | 587.0 |
| | Siemens Immulite 1000 | ng/ml | 53.3 | 345.0 | 769.0 |
| Insulin | Abbott Architect | mU/l | N/A | 8.31 | N/A |
| | Siemens Advia Centaur | mU/l | 6.08 | 10.3 | 28.0 |
| | Roche Cobas 6000/8000 | mU/l | N/A | 9.12 | N/A |
| | Roche Elecsys | mU/l | N/A | 8.38 | 29.7 |
| | Roche Cobas E411 | mU/l | 5.45 | 9.66 | 27.0 |
| Parathyroid Hormone (PTH) | Abbott Architect | pg/ml | 23.6 | 304.0 | 997.0 |
| | Siemens Immulite 1000 | pg/ml | 25.8 | 384.0 | 1102.0 |
| | Siemens Immulite 2000/2500 | pg/ml | 30.4 | 350.0 | 1130.0 |
| | Roche Elecsys | pg/ml | 21.2 | 185.0 | 591.0 |
| | Roche Cobas 6000/8000 | pg/ml | 17.8 | 172.0 | 547.0 |
| | Roche Modular E170 | pg/ml | N/A | N/A | 532.0 |
| | Siemens Advia Centaur | pg/ml | 27.4 | 293.0 | 1016.0 |
| Procalcitonin | bioMerieux Vidas | ng/ml | 1.33 | 2.47 | 18.9 |
| | Brahms Kryptor | ng/ml | N/A | 0.690 | 7.76 |
| | Brahms VIDAS PCT | ng/ml | N/A | 2.41 | N/A |
| | Siemens Advia Centaur | ng/ml | 2.31 | 3.23 | 19.5 |

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(NA refers to Not Applicable)

## Stability Studies:

Shelf-life and open-vial stability protocols and acceptance criteria were reviewed and found to be acceptable.

Shelf-life stability studies: Accelerated stability was used to predict the shelf life of control materials. The Immunoassay Speciality Controls (I) were stored at +37°C for a period of two weeks. The shelf life of these products was set at 2 years from the date of manufacture, based on the performance of the accelerated stability testing. The real time stability of the controls was monitored to verify and validate the predicted or desirable shelf life. Current Real Time studies support a 2 year shelf life.

Open-vial stability studies: The Immunoassay Speciality (I) Controls were reconstituted as instructed on the product insert sheet and stored at +2 to +8°C until testing at different time points. The studies support a reconstituted stability claim of 5 days at +2°C to +8°C for Insulin, Anti-TPO and 1,25 (OH) Vitamin D, 3 days at +2°C to +8°C for Anti-TG, and 1 day at +2°C to +8°C for C-Peptide, IGF-1, and Procalcitonin. Parathyroid hormone (PTH) should be tested within 4 hours of reconstitution when stored at +2°C to +8°C.

Frozen stability studies were designed to establish the stability of each analyte in frozen serum. Samples were reconstituted and stored at -18 to -24°C for 28 days. The current studies support a frozen stability claim of 4 weeks when stored frozen at -20°C. Parathyroid hormone (PTH) should be tested within 2 weeks when stored below -20°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

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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 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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