RANDOX LIQUID CRP CONTROLS

K040351 · Randox Laboratories, Ltd. · JJX · Mar 12, 2004 · Clinical Chemistry

Device Facts

• Record ID: K040351
• Device Name: RANDOX LIQUID CRP CONTROLS
• Applicant: Randox Laboratories, Ltd.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Mar 12, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The Randox Laboratories Ltd. CRP Controls are liquid controls containing human recombinant CRP in a stabilized protein matrix. They have been developed for use in the control of both accuracy and precision in CRP assays. The Randox Liquid C-Reactive Protein Controls should only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.

Device Story

Liquid control material containing recombinant human CRP in stabilized protein matrix; used to monitor accuracy/precision of clinical chemistry immunoturbidimetric CRP assays. Operated by qualified laboratory personnel in clinical settings. Product provides known concentration levels (Level II ~20 mg/L, Level III ~150 mg/L) to verify assay performance against CRM470 standards. Healthcare providers use output to validate laboratory testing procedures and ensure reliable patient results.

Clinical Evidence

No clinical data. Bench testing only. Stability studies support 18-month shelf life at 2-8 °C. Value assignment validated via comparison of test lots against master lots stored at -80 °C using 10 replicates.

Technological Characteristics

Liquid control material; recombinant human CRP in stabilized protein matrix. Traceable to CRM470. Storage 2-8 °C. Stability 18 months unopened/opened.

Indications for Use

Indicated for use as quality control materials to monitor the accuracy and precision of C-Reactive Protein (CRP) assays in clinical laboratory settings. Intended for use by qualified laboratory personnel.

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)

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

A. 510(k) Number:
K040351

B. Analyte:
C-Reactive Protein (CRP)

C. Type of Test:
Calibration Verification Material

D. Applicant:
Randox Laboratories Ltd.

E. Proprietary and Established Names:
Randox Liquid CRP Controls

F. Regulatory Information:
1. Regulation section:
21 CFR §862.1160 Single (Specified) Analyte Control (Assayed or Unassayed)
2. Classification:
Class I
3. Product Code:
JJX
4. Panel:
Clinical Chemistry (75)

G. Intended Use:
1. Intended use(s):
"The Randox Laboratories Ltd. CRP Controls are liquid controls containing human recombinant CRP in a stabilized protein matrix. They have been developed for use in the control of both accuracy and precision in CRP assays. The Randox Liquid C-Reactive Protein Controls should only be used by suitably qualified laboratory personnel under appropriate laboratory conditions."
2. Special condition for use statement(s):
none
3. Special instrument Requirements:
The sponsor states this product is intended for use on any clinical chemistry analyzer using a immunotubidimetric CRP assay which is standardized to the international reference preparation CRM470.

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H. Device Description:
This is a liquid product containing recombinant human CRP spiked into a stabilized protein matrix at the desired concentration (Level II ~ 20 mg/L, Level III ~150 mg/L).

I. Substantial Equivalence Information:
1. Predicate device name(s):
Bio-Rad Liquichek Immunology Control Levels 1, 2 and 3
2. Predicate K number(s):
K011494
3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | Assayed quality control material is intended to monitor laboratory testing procedures | Same |
| Form | Liquid | Same |
| Storage | 2 – 8 °C | Same |
| Matrix | Human serum based with stabilizers and preservatives | Same |
| Analyte | Single – CRP | Multiple, including CRP |
| Differences | | |
| Item | Device | Predicate |
| Levels | 2 levels | 3 levels |
| Stability-unopened | 2 -8 °C for 18 months | 2 -8 °C for 90 days |
| Stability-opened | 2 – 8 °C for 18 months | 2 – 8 °C for 30 days |

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

K. Test Principle:
N/A

L. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:
N/A
b. Linearity/assay reportable range:
N/A
c. Traceability (controls, calibrators, or method):
The sponsor states traceability to CRM 407.

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Assignment of values follows an internal QC procedure. A test lot is compared to a master lot stored at -80 °C. Ten replicates of test lot and master lot are run and then calculation of value is based on results obtained. The value must be within the manufacturing range specified for the product.

Real-time stability studies were performed and support a stability claim of 18 months when stored at 2-8 °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:

Representative Assigned Values for Levels II and III

| Level | Lot # | Assigned Value (mg/L) | Acceptable Range (mg/L) |
| --- | --- | --- | --- |
| II | 1199CP | 21.3 | 17.0 – 25.6 |
| III | 1189CP | 150 | 120 - 180 |

M. Conclusion:
I recommend that Randox Liquid CRP Controls be found to be substantially equivalent to the predicate.