CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2

K081908 · Cliniqa Corporation · JJW · Jan 16, 2009 · Clinical Chemistry

Device Facts

• Record ID: K081908
• Device Name: CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2
• Applicant: Cliniqa Corporation
• Product Code: JJW · Clinical Chemistry
• Decision Date: Jan 16, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

CLINIQA® Liquid QC™ DipScopics Urinalysis Control is intended for use as an assayed quality control material for various urinalysis reagent strips, qualitative hCG methods as well as confirmatory tests such as Acetest®, Clinitest®, and Ictotest®. This control is also intended to evaluate microscopic examination test procedures.

Device Story

CLINIQA® Liquid QC™ Urinalysis Controls (Levels 1 and 2) are ready-to-use liquid quality control materials; composed of human urine base blended with salts, stabilizers, preservatives, buffers, plant-based materials, and purified human proteins. Designed to mimic clinical urine samples containing specific analytes: Glucose, Bilirubin, Ketones, specific gravity, blood, pH, protein, Urobilinogen, Nitrite, leukocytes, hCG, Microalbumin, Creatinine, Galactose, red blood cells, white blood cells, and crystals. Used by laboratory personnel to verify performance of urinalysis reagent strips, qualitative hCG assays, confirmatory tests (e.g., Acetest, Clinitest, Ictotest), and microscopic examination procedures. Controls are donor-tested for infectious diseases (HBsAg, HIV, HCV). Healthcare providers compare test results obtained using these controls against lot-specific expected values provided in the product insert to ensure analytical accuracy and reliability of patient testing.

Clinical Evidence

No clinical data. Bench testing only. Stability claims supported by Arrhenius model accelerated temperature studies and real-time stability testing (1.5 years closed-vial at 2-8 °C; 90 days open-vial at 2-8 °C or 30 days at 20-25 °C).

Technological Characteristics

Liquid-based quality control material; assayed for urinalysis reagent strips, hCG, and confirmatory tests. Class I (Reserved) device under 21 CFR 862.1660.

Indications for Use

Indicated for use as an assayed quality control material for urinalysis reagent strips, qualitative hCG methods, confirmatory tests, and microscopic examination test procedures in clinical 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.

Submission Summary (Full Text)

{0}

1

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

A. 510(k) Number:
k081908

B. Purpose for Submission:
New Device

C. Measurand:
Multiple constituents in urine (Glucose, Bilirubin, Ketones, specific gravity, blood, pH, protein, Urobilinogen, Nitrite, leukocytes, hCG, Microalbumin, Creatinine, Galactose, red blood cells, white blood cells, and crystals)

D. Type of Test:
Not applicable

E. Applicant:
CLINIQA Corporation

F. Proprietary and Established Names:
CLINIQA® Liquid QC™ Urinalysis Controls, Levels 1 and 2

G. Regulatory Information:
1. Regulation section:
21 CFR § 862.1660 Quality control material (assayed and unassayed)
2. Classification:
Class I (reserved)
3. Product code:
JJW, Urinalysis Controls (Assayed and Unassayed)
4. Panel:
Clinical Chemistry (75)

H. Intended Use:
1. Intended use(s):
CLINIQA® Liquid QC™ DipScopics Urinalysis Control is intended for use as an assayed quality control material for various urinalysis reagent strips, qualitative hCG methods as well as confirmatory tests such as Acetest®, Clinitest®, and Ictotest®. This control is also intended to evaluate microscopic examination test procedures.
2. Indication(s) for use:
See Intended Use section above

{1}

3. Special conditions for use statement(s):
For In Vitro Diagnostic Use
For Prescription Use Only

4. Special instrument requirements:
The instruments are listed in the product insert.

I. Device Description:
CLINIQA® Liquid QCTM Urinalysis Controls, Levels 1 and 2 are prepared by blending together various salts, stabilizers, preservatives, buffers, plant based materials, human based materials and purified human proteins with a human urine base to achieve the desired manufacturing targets for Glucose, Bilirubin, Ketones, specific gravity, blood, pH, protein, Urobilinogen, Nitrite, leukocytes, hCG, Microalbumin, Creatinine, Galactose, red blood cells, white blood cells, and crystals. The controls are provided in ready-to-use liquid form.

Each human donor unit used to manufacture this product was tested for Hepatitis B Surface Antigen (HBsAg), HIV-1 antigen, antibody to Hepatitis C Virus (HCV), and antibody to HIV-1/2 and found non-reactive using FDA accepted test methods.

J. Substantial Equivalence Information:

1. Predicate device name(s):
Quantimetrix Urine Dipstick Control; Quantimetrix Urinalysis Microscopics Control

2. Predicate 510(k) number(s):
k874890; k925256

3. Comparison with predicate:
All are human urine based products containing analytes at clinically relevant concentrations. The difference between the predicate devices and the CLINIQA device is the constituents and their target concentrations.

K. Standard/Guidance Document Referenced (if applicable):
No standards 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

{2}

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

Traceability: Traceability was not provided.

Stability: Closed vial stability: the Arrhenius model of accelerated elevated temperature studies was used to support CLINIQA® Liquid QCTM Urinalysis Controls, Levels 1 and 2 storage stability at 2-8 °C. The controls are stable for 1.5 years when stored unopened at 2-8 °C. CLINIQA® Liquid QCTM Urinalysis Controls, Levels 1 and 2 have been on real time stability for over 10 months to support the closed-vial stability claim at 2-8 °C.

Open vial stability: the Arrhenius model of accelerated elevated temperature studies was used to support CLINIQA® Liquid QCTM Urinalysis Controls, Levels 1 and 2 storage stability at 2-8 °C. The controls are stable for 90 days when stored tightly capped at 2-8 °C or 30 days when stored at 20-25 °C. CLINIQA® Liquid QCTM Urinalysis Controls, Levels 1 and 2 have been on real time stability for 40 days to support the open-vial stability claim at 2-8 °C.

Expected values: The expected values printed on the CLINIQA® Liquid QCTM Urinalysis Controls, Levels 1 and 2 product insert will be specific to that lot. The values will be obtained from replicate assays derived by multiple laboratories using the test methodologies listed in the product insert. Multiple data points will be used to determine the mean (expected) value. Assignment of values will be performed using the reagents, calibrators, and controls available at the time of assay by the instrument manufacturer.

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

{3}

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.

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

4