VALIDATE URINE CHEMISTRY CALIBRATION VERIFICATION TEST SETS

K050504 · Maine Standards Co. · JJY · Mar 25, 2005 · Clinical Chemistry

Device Facts

• Record ID: K050504
• Device Name: VALIDATE URINE CHEMISTRY CALIBRATION VERIFICATION TEST SETS
• Applicant: Maine Standards Co.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Mar 25, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The VALIDATE® Urine Chemistry Calibration Verification Test Sets are used by trained laboratory professionals for quantitatively verifying calibration, validating reportable ranges, and determining linearity in automated, semi-automated and manual chemistry systems for the analytes listed on the package insert.

Device Story

VALIDATE® Urine Chemistry Calibration Verification Test Sets consist of three kits (UC1, UC2, OSMO) containing multi-level liquid samples in human urine or serum matrix. Used by trained laboratory professionals in clinical chemistry settings to verify instrument calibration, reportable ranges, and linearity. Levels 1 and 5 are prepared to match instrument manufacturer's claimed linearity limits; intermediate levels (2, 3, 4) are created via admixture. Samples are assayed on clinical chemistry analyzers; recovered values are compared against expected tolerances to validate system performance. Benefits include ensuring accuracy and reliability of patient test results across the analytical measurement range.

Clinical Evidence

No clinical data. Bench testing only. Performance was validated by assaying levels 1 and 5 in triplicate on clinical chemistry analyzers to confirm they meet manufacturer-claimed linearity limits. Admixtures (levels 2, 3, 4) were subsequently tested in triplicate to verify recovery within required tolerances. Final in-process testing (FIPT) was performed in triplicate for all analytes in each level.

Technological Characteristics

Multi-level calibration verification material; human urine or serum-based matrix; liquid, ready-to-use form factor; stored at 2-8°C. Analytes include UA, ETOH, NA, K, CL, GLU, UUN, UTP, CA, MG, PHOS, CREAT, AMY, p-AMY, MA, and osmolality. No software or electronic components.

Indications for Use

Indicated for trained laboratory professionals to verify calibration, validate reportable ranges, and determine linearity of automated, semi-automated, and manual chemistry systems for specific urine and serum analytes.

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

• VALIDATE® Chemistry 1 Calibration Verification Test Set (k012117)
• Bio-Rad Liquichek™ Urine Chemistry Controls (k934357)

Submission Summary (Full Text)

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

## A. 510(k) Number:
k050504

## B. Purpose for Submission:
Notification of intent to manufacture and market the device: VALIDATE® Urine Chemistry Calibration Verification Test Sets.

## C. Measurand:

**UC1:**
Set 1 - Uric Acid
Set 2 - Ethyl Alcohol, Sodium, Potassium, Chloride, Glucose, Bun/Urea, and Urine Protein

**UC2:**
Set 1 – Calcium, Magnesium, Phosphorus, and Creatinine
Set 2 - Amylase, Pancreatic Amylase, and Microalbumin

**OSMO:**
Set 1 – Serum osmolality
Set 2 – Urine osmolality

## D. Type of Test:
Calibration Verification Material

## E. Applicant:
Maine Standards Company

## F. Proprietary and Established Names:
Proprietary – VALIDATE® Urine Chemistry Calibration Verification Test Sets.
Established Name – Quality Control Material

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G. Regulatory Information:

1. Regulation section:
21 CFR 862.1660

2. Classification:
Class I (reserved)

3. Product code:
JJY

4. Panel:
75, Chemistry

H. Intended Use:

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

2. Indication(s) for use:
The VALIDATE® Urine Chemistry Calibration Verification Test Sets are used by trained laboratory professionals for quantitatively verifying calibration, validating reportable ranges, and determining linearity in automated, semi-automated and manual chemistry systems for the analytes listed on the package insert.

3. Special conditions for use statement(s):
The VALIDATE® Urine Chemistry Calibration Verification Test Sets are used by trained laboratory professionals. They are not intended for use as routine quality control materials or as calibration materials. They are not intended for use with systems employing reflectance spectroscopy.

4. Special instrument requirements:
Clinical chemistry analyzers

I. Device Description:
The VALIDATE® Urine Chemistry Calibration Verification Test Sets are

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comprised of three separate kits designated as UC1, UC2, and OSMO. Each kit of UC1, UC2 consists of two bottles each of six levels including zero. The OSMO set consists of two bottles each of five levels. All sets are in a human or serum matrix compatible with chemistry systems.

Human source material from which this product has been derived has been tested at the donor level for the Human Immunodeficient Virus (HIV1, HIV2) antibody, Hepatitis B Surface Antigen (HbsAg) and Hepatitis C Virus (HCV) and found to be non-reactive. FDA approved methods have been used to conduct these tests.

## J. Substantial Equivalence Information:

1. Predicate device name(s):

VALIDATE® Chemistry 1 Calibration Verification Test Set

Bio-Rad Liquichek™ Urine Chemistry Controls

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

k012117, k934357

3. Comparison with predicate:

| | VALIDATE® Urine Chemistry Calibration Verification Test Sets | VALIDATE® Chemistry 1 Calibration Verification Test Set | Bio-Rad Liquichek™ Urine Chemistry Controls |
| --- | --- | --- | --- |
| Catalog# | 701/702/703 | 101 | 398 |
| Intended Use | For in vitro diagnostic use in quantitatively verifying calibration, validating reportable ranges, and determining linearity in automated, semi-automated and manual chemistry systems for the analytes listed on the package insert. | For in vitro diagnostic use in quantitatively verifying calibration, validating reportable ranges, and determining linearity in automated, semi-automated and manual chemistry systems for the analytes listed on the package insert. | For in vitro use as assayed quality control urine to monitor the precision of laboratory testing procedures for the listed analytes. |

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| | 701 – UC1 | Sodium, Potassium, Chloride, Calcium, Phosphorous, Glucose, BUN, Creatinine, Triglyceride, Magnesium, Lactate, Lithium | Amylase, Calcium, Chloride, Cortisol, Creatinine, Glucose, Magnesium, Microalbumin, Osmolality, Phosphorous, Potassium, Urine Total Protein, Sodium, BUN, UUN, Uric Acid |
| --- | --- | --- | --- |
| Analytes | Uric Acid, Alcohol, Sodium, Potassium, Chloride, Glucose, Urea nitrogen/urea, Total protein

702 – UC2
Calcium, Magnesium, Phosphorous, Creatinine, Amylase, Pancreatic amylase, Microalbumin

703 – Osmo
serum osmolality, urine osmolality | | |
| Matrix | Human urine, Human serum (osmo) | Aqueous | Human urine |
| Number of Levels | 701/702
6 including zero

703
5 levels | 6 including zero | 1 level |
| Preparation | Liquid ready to use | Liquid ready to use | Liquid ready to use |
| Packaging | 3.0 mL each level | 5.0 mL each level | 10 mL |
| Stability | Until Expiration | Until Expiration | 30 days after opening |
| Storage | 2 to 8°C | 2 to 8°C | 2 to 8°C |

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

None stated

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)

The test sets, Cat # 701 / 702 / 703, are prepared in a human urine matrix to which analytes of a chemical or biological (human or animal) nature are added along with preservatives, stabilizers, and other excipients. The concentration of the added chemicals or biologicals are subsequently measured on various clinical chemistry analyzer systems using methods designed for measurement of these analytes in human urine. Levels 1 and 5 are prepared so that Level 1 meets the lower limit of the instrument manufacturer's claimed linearity and Level 5 the upper limit. Levels 1 and 5 are assayed in triplicate on the applicable instrument system. When the recovered values meet the acceptance tolerance, admixtures of Levels 1 and 5 are made to create Levels 2, 3 and 4. Levels 2, 3 and 4 are then tested, again in triplicate, to validate that recovery meets the required tolerance. After this testing event, all levels are labeled and filled after which final in process testing (FIPT) is performed, again in triplicate, for all analytes in each level. Each testing event requires each level be assayed in triplicate on the system for which the product is designed.

d. Detection limit

Not Applicable

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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

4. Clinical cut-off:
Not Applicable

5. Expected values/Reference range:
Not Applicable

N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

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O. Conclusion:

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

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