VITAL SERUM CONTROLS

K111063 · Vital Diagnostics (Manufacturing) Ptyltd · JJY · Jun 28, 2011 · Clinical Chemistry

Device Facts

• Record ID: K111063
• Device Name: VITAL SERUM CONTROLS
• Applicant: Vital Diagnostics (Manufacturing) Ptyltd
• Product Code: JJY · Clinical Chemistry
• Decision Date: Jun 28, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

Vital Diagnostics Serum Controls are assayed multi-analyte quality control material. Vital Diagnostics Serum Controls are 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. An assayed quality control material may be used for proficiency testing in inter laboratory surveys.

Device Story

Vital Diagnostics Serum Controls are lyophilized human serum-based quality control materials; supplemented with human/non-human enzymes, non-protein constituents, and bacteriostatic agents. Used in clinical chemistry laboratories to monitor test system precision and detect systematic analytical deviations caused by reagent or instrument variation. Provided in two levels per analyte; packaged in 5 mL glass amber bottles. Operators (laboratory technicians/clinicians) use the controls within an analytical test system; results are compared against assigned values provided in labeling to verify instrument performance. Benefits include ensuring accuracy and reliability of diagnostic assay results for patient testing.

Clinical Evidence

No clinical data. Bench testing only. Stability studies (real-time) support a 4-year shelf life at 2-8°C and open-vial stability of 7 days at 2-8°C or 31 days at -20°C. Traceability established via NIST SRMs and recognized reference methods.

Technological Characteristics

Lyophilized human serum matrix; contains human/non-human enzymes, non-protein constituents, and bacteriostatic agents. Two levels provided. Storage at 2-8°C. Traceable to NIST SRMs and established reference methods (e.g., CDC HDL-C reference method). Compatible with ATAC 8000 and ENVOY 500 analyzers (with specific TIBC exclusion for ENVOY 500).

Indications for Use

Indicated for use as an assayed multi-analyte quality control material in clinical laboratory test systems to estimate test precision and detect systematic analytical deviations arising from reagent or instrument variation. May be used for proficiency testing in inter-laboratory surveys.

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)

{0}

1

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

A. 510(k) Number:
k111063

B. Purpose for Submission:
New device

C. Measurand:
Quality control materials for the following analytes: Albumin, Calcium, Cholesterol, Creatinine, Direct Bilirubin, Iron, Glucose, Magnesium, Phosphorus, Total Bilirubin, Total Protein, Triglycerides, Urea Nitrogen, Uric Acid, Alkaline Phosphatase, Amylase, HDL-Cholesterol, LDL-Cholesterol, Creatinine Kinase, g-Glutamyltransferase, Aspartate Aminotransferase, Alanine Aminotransferase, Total Iron – Binding Capacity, Lactate Dehydrogenase, Potassium, Sodium, Chloride, Carbon Dioxide

D. Type of Test:
Not applicable

E. Applicant:
Vital Diagnostics, Inc.

F. Proprietary and Established Names:
Vital Serum Controls

G. Regulatory Information:
1. Regulation section:
21 CFR 862.1660
2. Classification:
Class 1, reserved
3. Product code:
JJY
4. Panel:
75 Clinical chemistry

H. Intended Use:
1. Intended use(s):
Refer to indications for use below.
2. Indication(s) for use:
Vital Diagnostics Serum Controls are assayed multi-analyte control material.
Vital Diagnostics Serum Controls are 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. An assayed quality

{1}

control material may be used for proficiency testing in inter laboratory surveys.

3. Special conditions for use statement(s):
For in vitro diagnostic use only. For prescription use.

4. Special instrument requirements:
The package insert lists the following instruments:
ATAC 8000 Analyzer
ENVOY 500 Analyzer with the exception of Total Iron – Binding Capacity (TIBC). TIBC is not intended for use on the ENVOY 500 analyzer.

I. Device Description:
Vital Diagnostics Serum Controls are lyophilized human serum to which human and non-human enzymes, non-protein constituents and bacteriostatic agents have been added. Two levels of control per analyte are provided. Each level is packaged into a glass amber bottle containing 5 mL of product. The product is packaged in multiple level boxes (6 x 5 mL) intended to be stored at 2 – 8 °C. The source material has been tested by FDA approved methods and found non reactive for Hepatitis B surface antigen, Hepatitis C and the antibody to HIV ½.

J. Substantial Equivalence Information:

1. Predicate device name(s):
Randox Precision-Multi-Sera-Human, normal and elevated

2. Predicate 510(k) number(s):
k942458

3. Comparison with predicate:

| Comparison Table | | |
| --- | --- | --- |
| Characteristics | New Device (k111063) | Predicate (k942458) |
| Intended use | Intended for in vitro diagnostic use in the quality control of diagnostic assays | Same |
| Matrix | Human serum | Same |
| Form | Lyophilized | Same |
| Levels | Two | Same |
| Storage | 2-8°C | Same |
| Reconstituted stability | 7 days at -20°C | Same |
| Shelf Life | 36-48 months | 24 months |
| Analytes | Albumin, Calcium, Cholesterol, Creatinine, Direct Bilirubin, Iron, | Albumin, Calcium, Cholesterol, Creatinine, Direct Bilirubin, Iron, |

{2}

| Comparison Table | | |
| --- | --- | --- |
| Characteristics | New Device (k111063) | Predicate (k942458) |
| | Glucose, Magnesium, Phosphorus, Total Bilirubin, Total Protein, Triglycerides, Urea Nitrogen, Uric Acid, Alkaline Phosphatase, Amylase, HDL-Cholesterol, LDL-Cholesterol, Creatinine, Phosphokinase, g-Glutamyltransferase, Aspartate Aminotransferase, Alanine Aminotransferase, Total Iron – Binding Capacity* (TIBC), Lactate Dehydrogenase, Potassium, Sodium, Chloride, Carbon Dioxide | Glucose, Magnesium, Phosphorus, Total Bilirubin, Total Protein, Triglycerides, Urea Nitrogen, Uric Acid, Alkaline Phosphatase, Amylase, HDL-Cholesterol, LDL-Cholesterol, Creatinine Phosphokinase, g-Glutamyltransferase, Aspartate Aminotransferase, Alanine Aminotransferase, Total Iron – Binding Capacity, Lactate Dehydrogenase, Potassium, Sodium, Chloride, Carbon Dioxide Cholinesterase, Lipase, Cortisol, Digoxin, Hydroxybutyrate, IgA, IgG, IgM, Lactate, Lithium, Acid Phosphatase, PSA, Salicylate, Thyroxin |

*TIBC is intended for use on the ATAC 800 analyzer only.

K. Standard/Guidance Document Referenced (if applicable):
Guidance for Industry and FDA Staff: Assayed and Unassayed Quality Control Material

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):

{3}

Controls are traceable to the reference material shown in the table below:

| Traceability: Reference material | |
| --- | --- |
| Albumin | NIST SRM 927/CRM 470 |
| Calcium | NIST SRM 915b |
| Cholesterol | NIST SRM 911c/909b/1952a |
| Creatinine | NIST SRM 967b |
| Direct Bilirubin | Roche Calibrator for Automated Systems |
| Glucose | NIST SRM 917b |
| Iron | NIST SRM 937 |
| Magnesium | NIST SRM 3131a |
| Phosphorus | NIST SRM 3139a now available |
| Total Bilirubin | NIST SRM 916a |
| Total Protein | NIST SRM 927 |
| Triglycerides | NIST SRM 1951b / 909b |
| Urea Nitrogen | NIST SRM 912a |
| Uric Acid | NIST SRM 913a, SRM 909b |
| Alkaline Phosphatase | Extinction coefficient of 4 nitrophenol at 405nm / ε= 18.45 |
| Amylase | Extinction coefficient of 2-chloro-4-nitrophenol at 405 nm /ε = 15.0 |
| HDL, Cholesterol | CDC HDL-C Reference Method |
| LDL, Cholesterol | National Reference System for Cholesterol |
| Creatine Kinase | Extinction coefficient of NADH at 340nm /ε = 6.3 |
| γ-Glutamyltransferase | Extinction coefficient of 5-amino-2-nitrobenzoate at 405 nm / ε = 9.5 |
| Aspartate Aminotransferase | Extinction coefficient of NADH at 340nm /ε = 6.3 |
| Alanine Aminotransferase | Extinction coefficient of NADH at 340nm /ε = 6.3 |
| Total Iron Binding Capacity* (TIBC) | NIST SRM 937 |
| Lactate Dehydrogenase | Extinction coefficient of NADH at 340nm /ε = 6.3 |
| Potassium | NIST SRM 918 |
| Sodium | NIST SRM 919 |
| Chloride | NIST SRM 918/919 |
| Carbon Dioxide | SRM 351a ACS Sodium Carbonate Standard |

*TIBC is intended for use on the ATAC 800 analyzer only.

## Value assignment:

Expected values are determined using selected commercially available reference materials/standards and at least five vials of candidate control materials, two analyzers per each analyzer type, and two lots of reagents. The target value for each analyte is the mean of the observed 16 replicates. Control assigned values are lot dependent and are listed in the labeling. The mean and ranges are provided in tabular form in the value assignment sheets.

## Stability:

Shelf-Life and Open Vial Stability testing protocols and acceptance criteria were described and found to be adequate.

Shelf-Life – The sponsor provided real time stability data to support data

{4}

demonstrating that the Vital Diagnostics Serum Controls can be stored for 4 years at 2-8 °C.

Open-vial – The sponsor provided data demonstrating that upon opening a vial, the material is stable for 7 days at 2-8 °C and 31 days -20°C.

**Value Assignment:**
Instruments used for the value assignment included ATAC 8000 and ENVOY 500 analyzers.

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

{5}

4. Clinical cut-off:
Not applicable

5. Expected values/Reference range:
Expected values are provided in the value assignment sheets provided with the package insert

N. Proposed Labeling:
The labeling is sufficient and 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.

6