IRMA TRUPOINT CREATININE CONTROL KIT

K050983 · International Technidyne Corporation · JJX · May 16, 2005 · Clinical Chemistry

Device Facts

• Record ID: K050983
• Device Name: IRMA TRUPOINT CREATININE CONTROL KIT
• Applicant: International Technidyne Corporation
• Product Code: JJX · Clinical Chemistry
• Decision Date: May 16, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The IRMA TRUpoint™ Creatinine Control Kit is for use on the IRMA TRUpoint™ Blood Analysis System to perform Quality Control assays for Creatinine on the IRMA TRUpoint™ Blood Analysis System. For Prescription Use Only

Device Story

The IRMA TRUpoint™ Creatinine Control Kit provides assayed quality control materials to monitor the performance of the IRMA TRUpoint™ Blood Analysis System. The kit consists of aqueous-based solutions of creatinine and sucrose, packaged in 1.5 ml luer lock syringes at two distinct concentration levels. These controls are used by laboratory personnel or clinicians to verify the accuracy and precision of the IRMA analyzer's creatinine measurements. By running these controls, users ensure the system is functioning within expected parameters, thereby supporting reliable clinical decision-making for patient creatinine testing. The device contains no human or biological materials.

Clinical Evidence

No clinical data. Bench testing only. Stability testing conducted on 4 lots for closed container (2-8 °C) and 3 lots for open container (1 hour stability). Value assignment based on ANSI ASQ Z1.4 standard.

Technological Characteristics

Aqueous-based solution containing creatinine, sucrose, and dye. Non-biological. Form factor: capped luer lock syringes. Storage: 2-8 °C. Value assignment follows ANSI ASQ Z1.4 standard. Matrix effects evaluated per NCCLS EP-14A.

Indications for Use

Indicated for use as assayed quality control materials for the IRMA TRUpoint™ Blood Analysis System to perform quality control assays for creatinine. For in vitro diagnostic use.

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

• Bionostics Inc. RNA 823 Controls (k943754)
• Medical Analysis Systems Moni-Trol H Controls (k030942)

Submission Summary (Full Text)

{0}

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

A. 510(k) Number:
k050983

B. Purpose for Submission:
New Device

C. Analyte:
Creatinine

D. Type of Test:
Control Material

E. Applicant:
International Technidyne Corp.

F. Proprietary and Established Names:
IRMA TRUpoint™ Creatinine Control Kit

G. Regulatory Information:
1. Regulation section:
21 CFR 862.1660 Quality control material (assayed and unassayed).
2. Classification:
Class I, Reserved
3. Product Code:
JJX
4. Panel:
75, Chemistry

H. Intended Use:
1. Intended use(s):
See Indicaitons for Use Below
2. Indication(s) for use:
The IRMA TRUpoint™ Creatinine Control Kit is for use on the IRMA
TRUpoint™ Blood Analysis System to perform Quality Control assays for
Creatinine on the IRMA TRUpoint™ Blood Analysis System.
3. Special condition for use statement(s):
For Prescription Use Only
4. Special instrument Requirements:
IRMA TRUpoint™ Blood Analysis System

I. Device Description:
The IRMA TRUpoint™ Creatinine Control Kit is an assayed bi-level control used on
the IRMA TRUpoint™ Blood Analysis System. The kit contains three capped luer
lock syringes for each level. The control contains no human or biological materials.
The IRMA TRUpoint™ Creatinine Control Kit is an aqueous based solution of
creatinine and sucrose.

{1}

Page 2 of 4

# J. Substantial Equivalence Information:

1. Predicate device name(s):
Bionostics Inc. RNA 823 Controls and Medical Analysis Systems Moni-Trol H Controls
2. Predicate K number(s):
k943754 and k030942
3. Comparison with predicate:

| Similarities | | | |
| --- | --- | --- | --- |
| Item | Device | Predicate #1 | Predicate #2 |
| Intended Use | The IRMA TRUpoint™ Creatinine Control Kit are assayed quality control materials and are intended to be used to perform Quality Control assays for Creatinine on the IRMA TRUpoint™ Blood Analysis System. | RNA Medical Brand QC Blood Gas Electrolyte Metabolite Bun control is an assayed quality control material used for monitoring the performance of blood gas, electrolyte, metabolite, and BUN (urea) instrumentation for analytes and analyzers. | Moni-Trol H is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations. |
| Form | Aqueous | Aqueous | Aqueous |
| Differences | | | |
| Item | Device | Predicate #1 | Predicate #2 |
| Open Stability | 1 Hour | Immediately | 14 days |
| Levels | Two | Three | Three |
| Closed Stability | 2-8 °C | 2-8 °C | -20 °C |
| Analytes | Creatinine | pH, pCO2, pO2, iCa, Na, K, Cl, iMg, Glucose, Lactate and Urea | Creatinine plus 69 other analytes |

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

NCCLS EP-14A Evaluation of Matrix Effects

# L. Test Principle:

N/A

# M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility: N/A
b. Linearity/assay reportable range: N/A

{2}

Page 3 of 4

c. Traceability (controls, calibrators, or method):

The IRMA TRUpoint™ Creatinine Control kit is composed of non-biological creatine anhydrous, sucrose and dye.

The range and value assignment was based on ANSI ASQ Z1.4 standard and is dependant on lot size. For a lot size of 600, thirteen were tested to determine the range mean. The derived mean and range is fixed according to CAP/HCFA criteria of +/- 0.03 mg/dL or +/-15%, whichever is greater. The assigned values are chosen to span the expected medically relevant decision point (approximately 1.5 mg/dL) and to incorporate the upper region of the reportable range (approximately 7.5 mg/dL).

Closed Container Stability

Closed container stability testing was conducted on 4 lots of each control level. Each lot was stored at different temperatures 4, 10, 22 and 30 °C and analyzed at its 4 week shelf-life. The sponsor reports significant shifts at un-refrigerated temperatures in the mean results. The sponsor recommends refrigeration storage of 2-8 °C.

Open Container Stability

Open container stability testing was conducted on 3 lots of each control level. Two lots were evaluated through 2 hours and one lot through 3 days. No significant changes in mean or variability were observed and support the sponsors' claim of 1 hour open container stability.

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

{3}

Page 4 of 4

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