MULTI-CHEMISTRY STANDARD KIT, URIC ACID STANDARD KIT, URINE CHEMISTRY STARDAND KIT, URINE URIC ACID STANDARD KIT, CHOLES

K112834 · Verichem Laboratories, Inc. · JIX · Mar 28, 2012 · Clinical Chemistry

Device Facts

• Record ID: K112834
• Device Name: MULTI-CHEMISTRY STANDARD KIT, URIC ACID STANDARD KIT, URINE CHEMISTRY STARDAND KIT, URINE URIC ACID STANDARD KIT, CHOLES
• Applicant: Verichem Laboratories, Inc.
• Product Code: JIX · Clinical Chemistry
• Decision Date: Mar 28, 2012
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Indications for Use

The Verichem ISE Standard Kit is intended for the calibration of sodium, potassium, chloride, lithium, ionized calcium and carbon dioxide assays performed on a number of clinical chemistry instrument systems. A complete list of instrument models are found in the package insert. For in vitro diagnostic use only. The Verichem Multi-Chemistry Standard Kit is intended for the calibration of sodium, potassium, lactate, chloride, glucose, urea nitrogen, creatinine, calcium, phosphorus, magnesium and triglyceride assays performed on a number of clinical chemistry instrument systems. A complete list of instrument models are found in the package insert. For in vitro diagnostic use only. The Verichem Uric Acid Standard Kit is intended for the calibration of uric acid assays performed on a number of clinical chemistry instrument systems. A complete list of instrument models are found in the package insert. For in vitro diagnostic use only. The Verichem Urine Chemistry Standard Kit is intended for the calibration of sodium, potassium, chloride, urea nitrogen, creatinine, calcium, phosphorus and magnesium assays performed on a number of clinical chemistry instrument systems. A complete list of instrument models are found in the package insert. For in vitro diagnostic use only. The Verichem Urine Uric Acid Standard Kit is intended for the calibration of uric acid assays performed on a number of clinical chemistry instrument systems. A complete list of instrument models are found in the package insert. For in vitro diagnostic use only. The Verichem Cholesterol Standard Kit is intended for the calibration of total cholesterol assays performed on a number of clinical chemistry instrument systems. A complete list of instrument models are found in the package insert. For in vitro diagnostic use only. The Verichem Carbon Dioxide Standard Kit is intended for the calibration of carbon dioxide assays performed on a number of clinical chemistry instrument systems. A complete list of instrument models are found in the package insert. For in vitro diagnostic use only. The Verichem Electrolyte Standard Kit is intended for the calibration of sodium, potassium, lithium, chloride and ionized calcium assays performed on a number of clinical chemistry instrument systems. A complete list of instrument models are found in the package insert. For in vitro diagnostic use only. The Verichem ISE Standard (S4) is intended for the calibration of sodium, potassium, chloride and carbon dioxide assays performed on a number of clinical chemistry instrument systems. A complete list of instrument models are found in the package insert. For in vitro diagnostic use only.

Device Story

Verichem Diagnostic standard solutions are aqueous, primary calibrator materials containing known concentrations of specific analytes. Used in clinical chemistry laboratories to calibrate or verify the calibration of clinical chemistry instrument systems. Standardization is performed via gravimetric procedures; concentrations are verified using NIST Standard Reference materials. The device is provided as a kit; the healthcare provider (laboratory technician) uses the calibrator to adjust or validate the accuracy of the clinical chemistry analyzer's measurements. Proper calibration ensures the accuracy of patient test results, supporting clinical decision-making for various metabolic and electrolyte-related conditions.

Clinical Evidence

No clinical data. Bench testing only. Stability studies performed on multiple lots for each kit type, comparing stored standards to freshly prepared controls over periods ranging from 15 to 30 months to support shelf-life claims. Traceability established via NIST reference methods or primary standards.

Technological Characteristics

Aqueous, primary standard calibrator materials. Liquid form factor. Traceable to NIST reference materials or equivalent primary standards. Values assigned via gravimetric preparation. Storage at 2-8°C. No energy source or software components.

Indications for Use

Indicated for use as calibrators for clinical chemistry assays (sodium, potassium, chloride, lithium, ionized calcium, CO2, lactate, glucose, urea nitrogen, creatinine, calcium, phosphorus, magnesium, triglyceride, uric acid, cholesterol) on various clinical chemistry instrument systems. For prescription use in clinical laboratory settings.

Regulatory Classification

Identification

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• pHoenix Diagnostics ISE Standards (k023268)
• Multi-Chemistry Linearity Standard (k875285)
• Beckman – Synchron Multi - Calibrator (k110251)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

A. 510(k) Number:
k112834

B. Purpose for Submission:
New calibrator materials

C. Measurand:
Carbon Dioxide, Uric Acid, Cholesterol, Triglyceride, Sodium, Potassium, Chloride, Urea Nitrogen, Creatinine, Total Calcium, Phosphorus, Magnesium, Lithium, Ionized Calcium, Lactate, Glucose.

D. Type of Test:
Not Applicable

E. Applicant:
Verichem Laboratories, Inc.

F. Proprietary and Established Names:
- ISE Standard Kit
- Multi-Chemistry Standard Kit
- Uric Acid Standard Kit
- Urine Chemistry Standard Kit
- Urine Uric Acid Standard Kit
- Cholesterol Standard Kit
- Carbon Dioxide Standard Kit
- Electrolyte Standard Kit
- ISE Standard (S4)

G. Regulatory Information:
1. Regulation section:
21 CFR § 862.1150 - Calibrator
2. Classification:
Class II

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3. Product code:
JIX

4. Panel:
75 (Chemistry)

H. Intended Use:

1. Intended use(s):
See indications for use, below.

2. Indication(s) for use:
Device Name: ISE Standard Kit

Indications for Use:
The Verichem ISE Standard Kit is intended for the calibration of sodium, potassium, chloride, lithium, ionized calcium and carbon dioxide assays performed on a number of clinical chemistry instrument systems. A complete list of instrument models are found in the package insert. For in vitro diagnostic use only.

Device Name: Multi-Chemistry Standard Kit

Indications for Use:
The Verichem Multi-Chemistry Standard Kit is intended for the calibration of sodium, potassium, lactate, chloride, glucose, urea nitrogen, creatinine, calcium, phosphorus, magnesium and triglyceride assays performed on a number of clinical chemistry instrument systems. A complete list of instrument models are found in the package insert. For in vitro diagnostic use only.

Device Name: Uric Acid Standard Kit

Indications for Use:
The Verichem Uric Acid Standard Kit is intended for the calibration of uric acid assays performed on a number of clinical chemistry instrument systems. A complete list of instrument models are found in the package insert. For in vitro diagnostic use only.

Device Name: Urine Chemistry Standard Kit

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Indications for Use:

The Verichem Urine Chemistry Standard Kit is intended for the calibration of sodium, potassium, chloride, urea nitrogen, creatinine, calcium, phosphorus and magnesium assays performed on a number of clinical chemistry instrument systems. A complete list of instrument models are found in the package insert. For in vitro diagnostic use only.

Device Name: Urine Uric Acid Standard Kit

Indications for Use:

The Verichem Urine Uric Acid Standard Kit is intended for the calibration of uric acid assays performed on a number of clinical chemistry instrument systems. A complete list of instrument models are found in the package insert. For in vitro diagnostic use only.

Device Name: Cholesterol Standard Kit

Indications for Use:

The Verichem Cholesterol Standard Kit is intended for the calibration of total cholesterol assays performed on a number of clinical chemistry instrument systems. A complete list of instrument models are found in the package insert. For in vitro diagnostic use only.

Device Name: Carbon Dioxide Standard Kit

Indications for Use:

The Verichem Carbon Dioxide Standard Kit is intended for the calibration of carbon dioxide assays performed on a number of clinical chemistry instrument systems. A complete list of instrument models are found in the package insert. For in vitro diagnostic use only.

Device Name: Electrolyte Standard Kit

Indications for Use:

The Verichem Electrolyte Standard Kit is intended for the calibration of sodium, potassium, lithium, chloride and ionized calcium assays performed on a number of clinical chemistry instrument systems. A complete list of instrument models are found in the package insert. For in vitro diagnostic use only.

Device Name: ISE Standard (S4)

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Indications for Use:

The Verichem ISE Standard (S4) is intended for the calibration of sodium, potassium, chloride and carbon dioxide assays performed on a number of clinical chemistry instrument systems. A complete list of instrument models are found in the package insert. For in vitro diagnostic use only.

3. Special conditions for use statement(s):

For prescription use

4. Special instrument requirements:

A complete list of instrument models are found in the package inserts.

I. Device Description:

All calibrator materials included in this submission are aqueous, primary standards containing known amounts of each component for in vitro diagnostic use.

J. Substantial Equivalence Information:

1. Predicate device name(s):

pHoenix Diagnostics ISE Standards

Multi-Chemistry Linearity Standard

Beckman – Synchron Multi - Calibrator

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

k023268

k875285

k110251

3. Comparison with predicate:

| Feature | Candidate Device: Multi-Analyte Chemistry Standards (k112834) – CO2 Standard Kit Electrolyte Standard Kit ISE Standard Kit ISE Standard (S4) | Predicate Device: pHoenix Diagnostics ISE Standards (k023268) |
| --- | --- | --- |
| Intended Use | Used for calibration of | Same |

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| Feature | Candidate Device: Multi-Chemistry Standards (k112834) – Urine Chemistry Standard Kit | Predicate Device: Multi-Chemistry Linearity Standard (k875285) |
| --- | --- | --- |
| Intended Use | Used for the calibration of automated methods for the quantitative determination of analytes | Same |
| Format | Liquid | Same |
| Measurement of Analytes | sodium, potassium, lactate, chloride, glucose, urea nitrogen, creatinine, calcium, phosphorus, magnesium and triglyceride in serum
sodium, potassium, chloride, urea nitrogen, creatinine, calcium, phosphorus and magnesium in urine | Sodium, Potassium, Chloride, Urea nitrogen, Urea, Glucose, Creatinine, Calcium in serum |
| Feature | Candidate Device: Multi-Analyte Chemistry Standards (k112834) – Urine Uric Acid Standard Kit
Cholesterol and uric acid standard kits | Predicate Device: Beckman – Synchron Multi-Calibrator (k110251) |
| --- | --- | --- |
| Intended Use | Used for the calibration of automated methods for the quantitative determination of analytes | Same |

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| Format | of analytes | Same |
| --- | --- | --- |
| Measurement of Analytes | sodium, potassium, lactate, chloride, glucose, BUN, creatinine, calcium, phosphorus, magnesium, triglyceride, uric acid, and cholesterol in serum
Uric acid in urine | Lactate, magnesium, albumin, BUN, calcium, cholesterol, creatinine, glucose, inorganic phosphorus, total protein, triglycerides and uric acid in serum |

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

FDA Guidance for Industry - Abbreviated 510(k) Submissions for In Vitro Diagnostic Calibrators; Final Guidance for Industry – Version 2011. Date: 02/22/1999

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:

All standards contained within this submission are traceable to either NIST reference method materials or to equivalent primary standards if NIST is not available. Values are assigned by gravimetric preparations using a standard source of materials of known purity.

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# Stability:

## Carbon Dioxide Standard Kit:

Five (5) lots of carbon dioxide standards (5 levels, A through E) were evaluated at t=15 months and compared to a reference control. The standards used for the study were freshly prepared using standards stored for 15 months. The results of this study support the sponsor’s claimed stability of 15 months when stored at 2-8°C.

## Urine Chemistry Standard Kit:

Five (5) lots of urine chemistry standards (5 levels, A through E) were evaluated at t=19 months and compared to a reference control. The standards used for the study were freshly prepared using standards stored for 19 months. The results of this study support the sponsor’s claimed stability of 19 months when stored at 2-8°C.

## Electrolyte Standard Kit:

Five (5) lots of sodium, potassium, chloride, and lithium standards (5 serum levels of each analyte and 5 urine levels of sodium, potassium, and chloride) and five (5) lots of carbon dioxide standards (5 levels) were evaluated and compared to a reference control. The standards used for the study were freshly prepared for each standard type. The results of this study support a stability of 24 months for serum, 19 months for urine, and 15 months for CO2 when stored at 2-8 °C.

Additionally, five (5) lots of ionized calcium standards were evaluated at five (5) concentration levels and compared to a reference control. The standards used for the study were freshly prepared from storage. The results of this study supports a stability of 20 months when stored at 2-8°C.

## Cholesterol Standard Kit:

Five (5) lots of cholesterol standards (5 levels, 40 – 500 mg/dL) were evaluated at t=30 months and compared to a reference control. The standards used for the study were freshly prepared using standards stored for 30 months. The results of this study support the sponsor’s claimed stability of 30 months when stored at 2-8°C.

## Uric Acid Standard Kit:

Five (5) lots of uric acid standards (5 levels, 2.0 – 22.0 mg/dL) were evaluated at t=26 months and compared to a reference control. The standards used for the study were freshly prepared using standards stored for 26 months. The

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results of this study support the sponsor’s claimed stability of 26 months when stored at 2-8°C.

## ISE Standard Kit:

Five (5) lots of sodium, potassium, chloride, lithium, magnesium, and calcium standards (5 levels of each analyte) were evaluated at t=24 months and compared to a reference control. The standards used for the study were freshly prepared using standards stored for 24 months. The results of this study support the sponsor’s claimed stability of 24 months when stored at 2-8°C.

## ISE Standard (S4):

One (1) lot of sodium, potassium, chloride, and CO2 (1 level at a single concentration of each analyte) were evaluated at t=16 months and compared to a reference control. The standards used for the study were freshly prepared using standards stored for 16 months. The results of this study support the sponsor’s claimed stability of 16 months when stored at 2-28°C.

## Multi Chemistry Standard Kit:

Five (5) lots of standard kits containing five levels of the following analytes: creatinine, glucose, magnesium, phosphorus, potassium, sodium, triglyceride, and urea nitrogen at t=24 months for each analyte except for phosphorus (t=21 months) and compared to a reference control. The results of this study support the sponsor’s claimed stability of 21 months for when stored at 2-8°

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:
See each individual 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.