IRISPEC,CA/CB/CC

K072640 · Iris Diagnostics · JJW · Dec 21, 2007 · Clinical Chemistry

Device Facts

• Record ID: K072640
• Device Name: IRISPEC,CA/CB/CC
• Applicant: Iris Diagnostics
• Product Code: JJW · Clinical Chemistry
• Decision Date: Dec 21, 2007
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

IRISpec™ CA/CB/CC is an assayed QC material for monitoring of urine chemistry analytes and devices as listed on the package insert. For in vitro diagnostic (IVD) use only.

Device Story

IRISpec™ CA/CB/CC is a liquid, ready-to-use quality control material for urine chemistry analyzers and reagent strips. It consists of a synthetic matrix simulating human urine, containing preservatives and bovine-sourced biological materials (serum albumin, hemoglobin, bilirubin). The device is provided in three parts (CA, CB, CC); parts CA and CB are identical to the predicate device (K945913), while part CC includes an added claim for ascorbic acid (40 mg/dL). The device is used by laboratory personnel to monitor the performance of urine chemistry test systems. By testing the control material alongside patient samples, clinicians verify the accuracy and precision of the analytical system. The device provides a known concentration of analytes to ensure the diagnostic equipment is functioning within specified parameters, thereby supporting reliable clinical decision-making.

Clinical Evidence

Bench testing only. No clinical data. Analytical performance was verified by gravimetric addition of ascorbic acid to achieve ~40 mg/dL. Values were confirmed via repeat testing on iChem 100, Aution AX-4280, and Aution AJ-4270 analyzers. Comparison testing of three lots of CC control against human urine spiked with 40 mg/dL ascorbic acid showed no measurement differences. Stability protocols (real-time, open-vial, accelerated) confirmed a 6-month shelf life.

Technological Characteristics

Synthetic urine matrix with 0.0048% glutaraldehyde preservative; bovine-sourced serum albumin, hemoglobin, and bilirubin. Liquid form in 100 mL glass bottles. Refrigerated storage (2° to 8°C). 6-month closed-vial stability; 15-day open-vial stability.

Indications for Use

Indicated for use as an assayed quality control material for monitoring urine chemistry analytes and devices 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

• IRISpec™ Urine Chemistry Control CA and CB (k945913)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

A. 510(k) Number:
k072640

B. Purpose for Submission:
This submission is for the addition of a new control material containing ascorbic acid (CC) to the previously cleared IRISpec™ CA and CB urine chemistry control set. The new product is named IRISpec™ CA/CB/CC.

C. Measurand:
Quality control material for urine chemistry

D. Type of Test:
Not applicable

E. Applicant:
Iris International Inc.

F. Proprietary and Established Names:
IRISpec™ CA/CB/CC

G. Regulatory Information:
1. Regulation section:
CFR § 862.1660 Quality Control Material (assayed and unassayed)
2. Classification:
Class I, reserved
3. Product code:
JJW
4. Panel:

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Chemistry (75)

## H. Intended Use:

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

2. Indication(s) for use:
IRISpec™ CA/CB/CC is an assayed QC material for monitoring of the urine chemistry analytes and devices as listed on the package insert. For *in vitro* diagnostic (IVD) use only.

3. Special conditions for use statement(s):
Not applicable

4. Special instrument requirements:
iChem 100®, Aution AX-4280®, Aution AJ-4270®

## I. Device Description:

IRISpec™ CA/CB/CC controls are based on a synthetic matrix simulating human urine with preservatives. Bovine-sourced biological material is added for serum albumin, hemoglobin, and bilirubin. L-ascorbic acid is in the CC control material only. It does not contain human sourced materials.

IRISpec™ CA/CB/CC will be marketed as a set. IRISpec™ CC is not intended to be marketed as a stand-alone product.

## J. Substantial Equivalence Information:

1. Predicate device name(s):
IRISpec™ Urine Chemistry Control CA and CB

Note: The predicate device, IRISpec™ CA and CB, has been re-labeled as IRISpec™ CA/CB.

2. Predicate K number(s):
k945913

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3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Name | IRISpec™ CA/CB/CC Control | IRISpec™ CA/CB Control |
| Composition | CA and CB are identical to CA and CB of the predicate device. CC matrix is the same as CA/CB. | Synthetic matrix simulating human urine, with preservatives and bovine-sourced biological material for serum albumin, hemoglobin, and bilirubin. No human sourced materials. |
| Form | Same | Liquid, ready to use |
| Packaging-container | Same | Glass bottle with plastic screw cap |
| Packaging-fill volume | Same | 100 mL |
| Preservative | Same | 0.0048% gluteraldehyde |
| Storage | Same | 2° to 8°C until expiration date |
| Stability-closed vial | Same | 6 months at 2° to 8°C |
| Stability-open vial | Same | 15 days at 2° to 8°C |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Name | IRISpec™ CA/CB/CC Control | IRISpec™ CA/CB Control |
| Intended Use | IRISpec™ CA/CB/CC is an assayed QC material for monitoring of urine chemistry analytes and devices as listed on the package insert | The IRISpec Urine Chemistry Controls are intended to be used as a quality control material for all Chemstrip™ urine reagent strips |
| Analytes | Contains ascorbic acid in CC control | No ascorbic acid |

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

None

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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):
Ascorbic acid was added gravimetrically to the control material to obtain a positive result of approximately 40 mg/dL. Values were confirmed with repeat testing on each instrument.

Comparison testing was performed on three lots of the proposed CC control material and compared to human urine spiked with ascorbic acid at 40 mg/dL. Testing was performed in triplicate on the iChem 100 Urine Analyzer. No measurement differences were found.

Real time, open vial, and accelerated stability protocols were reviewed and found to be acceptable. The material has a 6 month shelf life.
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:

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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.

O. Conclusion:

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