QUANTIFY CONTROL AND QUANTIFY PLUS CONTROLS

K042446 · Bio-Rad Laboratories, Inc. · JJW · Nov 2, 2004 · Clinical Chemistry

Device Facts

• Record ID: K042446
• Device Name: QUANTIFY CONTROL AND QUANTIFY PLUS CONTROLS
• Applicant: Bio-Rad Laboratories, Inc.
• Product Code: JJW · Clinical Chemistry
• Decision Date: Nov 2, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

qUAntify® Control and qUAntify® Plus Control are intended for use as an assayed quality control to monitor the precision of urinalysis test procedures for the analytes listed in the package insert. For Prescription Use Only

Device Story

qUAntify® Control and qUAntify® Plus Control are liquid matrix quality control solutions used in clinical laboratories to monitor the precision of urinalysis test procedures. The controls contain human erythrocytes, leukocytes (in Plus version only), animal-derived constituents, chemicals, and preservatives. They are provided in two levels. Laboratory personnel use these controls to verify the performance of urinalysis assays by comparing observed results against assigned values provided in the package insert. This process ensures the reliability of patient test results for various analytes, including glucose, hCG, protein, and specific gravity, thereby supporting accurate clinical decision-making.

Clinical Evidence

No clinical data. Stability studies performed to determine open vial stability (31 days at 2-8°C or 18-25°C) and shelf life (two years at 2-8°C).

Technological Characteristics

Liquid matrix solution containing human erythrocytes, leukocytes, animal-derived constituents, chemicals, and preservatives (<0.1%). Analytes include albumin, creatinine, bilirubin, blood, glucose, hCG, ketones, leukocytes, nitrite, protein, pH, urobilinogen, and specific gravity. Storage at 2°C to 8°C. No software or electronic components.

Indications for Use

Indicated for use as an assayed quality control to monitor the precision of urinalysis test procedures for specified analytes in clinical laboratory 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.

Predicate Devices

• Liquichek™ Urinalysis Control (K031231)

Submission Summary (Full Text)

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
DEVICE ONLY TEMPLATE

A. 510(k) Number:
k042446

B. Purpose for Submission:
New Device

C. Analyte:
Urine Albumin, Albumin-to-Creatinine Ratio, Ascorbic Acid, Bilirubin, Blood, Creatinine, Glucose, hCG, Hemoglobin, Ketones, Leukocytes, Nitrite, Microalbumin, Protein-to-Creatinine Ratio, Protein (Total), pH, Urobilinogen, Specific Gravity

D. Type of Test:
Quantitative

E. Applicant:
Bio-Rad Laboratories

F. Proprietary and Established Names:
qUAntify® Control; qUAntify® Plus Control

G. Regulatory Information:
1. Regulation section:
21 CFR 862.1660 Quality Control Material (assayed and unassayed)
2. Classification:
Class I
3. Product Code:
JJW
4. Panel:
75

H. Intended Use:
1. Intended use(s):
Refer to Indications for use below.
2. Indication(s) for use:
qUAntify® Control and qUAntify® Plus Control are intended for use as an assayed quality control to monitor the precision of urinalysis test procedures for the analytes listed in the package insert.
3. Special condition for use statement(s):
For Prescription Use Only
4. Special instrument Requirements:
N/A

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I. Device Description:
These products are liquid matrix solutions prepared with human erythrocytes and [leukocytes in qUAntify® Plus only], constituents of animal origin, chemicals, and preservatives. They are prepared as Level 1 and Level 2.

J. Substantial Equivalence Information:
1. Predicate device name(s):
Liquicheck Urinalysis Control
2. Predicate K number(s):
k031231
3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | qUAntify Control and qUAntify Plus Control are intended for use as an assayed quality control to monitor the precision of urinalysis test procedures for the analytes listed in the package insert. | For use as an assayed quality control urine to monitor the precision of urinalysis test procedures for the analytes listed in the package insert. |
| Analytes | Albumin, Albumin-to-Creatinine Ratio, Ascorbic Acid, Bilirubin, Blood Creatinine, Glucose, hCG, Hemoglobin, Ketones, Leukocytes, Nitrite, Microalbumin, Protein-to-Creatinine Ratio, Protein (Total), pH, Urobilinogen, Specific Gravity, Crystals, Casts, Red Blood Cells, White Blood Cells | Bilirubin, Blood, Creatinine, Glucose, hCG, Ketones, Leukocytes, Nitrite, Microalbumin, Protein-to-Creatinine Ratio, Protein (Total), pH, Urobilinogen, Specific Gravity, Crystals, Casts, Red Blood Cells, White Blood Cells, Osmolality |
| Matrix | Liquid matrix solution | Human Urine |

K. Standard/Guidance Document Referenced (if applicable):
None Referenced

L. Test Principle:
Not Applicable

M. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:
Not Applicable

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b. Linearity/assay reportable range:
Not Applicable

c. Traceability (controls, calibrators, or method):
No traceability provided.
The product is a stabilized liquid product manufactured under rigid quality control standards. The value assignment data are generated through internal protocols with repeat analysis of the test kit or instrument used. The values are provided in the package insert.
Stability studies have been performed to determine the open vial stability and shelf life for the product. Product stability claims are as follows:
Open vial stability: 31 days at 2 to 8 C or room temperature (18-25° C).
Shelf life: Two years at 2 to 8° C.

d. Detection limit:
N/A

e. Analytical specificity:
N/A

f. Assay cut-off:
N/A

2. Comparison studies:
a. Method comparison with predicate device:
N/A
b. Matrix comparison:
N/A

3. Clinical studies:
a. Clinical sensitivity:
N/A
b. Clinical specificity:
N/A
c. Other clinical supportive data (when a and b are not applicable):
N/A

4. Clinical cut-off:
N/A

5. Expected values/Reference range:
N/A

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