ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB) ASSAY VERIFICATION SET

K060133 · Inverness Medical Innovations, Inc. · JJX · Feb 16, 2006 · Clinical Chemistry

Device Facts

• Record ID: K060133
• Device Name: ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB) ASSAY VERIFICATION SET
• Applicant: Inverness Medical Innovations, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Feb 16, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The Ischemia Albumin Cobalt Binding Test (ACB®) Assay Verification Set is intended for use in verifying accuracy of the ACB Test on the Roche Integra 700/800. It is recommended as a part of assay installation.

Device Story

The Ischemia ACB® Assay Verification Set consists of frozen, serum-based samples with assigned Ischemia Modified Albumin (IMA) values. It is used in clinical laboratory settings to verify the accuracy of the ACB Test on Roche Integra 700/800 analyzers, specifically during initial assay installation. By providing samples with known values across the physiological range, the device allows laboratory personnel to confirm that the analyzer is performing within expected parameters. This verification process ensures the reliability of the ACB Test results, which are used by clinicians to aid in the assessment of patients. The device is intended for in vitro diagnostic use.

Clinical Evidence

No clinical data. Bench testing only. The manufacturer confirmed target values internally by plotting average ACB values against volumes of cobalt chloride and EDTA, requiring a linear curve fit with an R² value of ≥ 0.95.

Technological Characteristics

The device consists of twenty (20) single-vial 0.5 mL aliquots of frozen, serum-based samples. It contains assigned IMA values spanning the physiological range. It is a quality control material classified under 21 C.F.R. § 862.1660 (Product Code JJX).

Indications for Use

Indicated for use as an assayed control material to verify the accuracy of the ACB Test on the Roche Integra 700/800 analyzer during assay installation.

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

• Maine Standards Company VALIDATE CHEM 3 Calibration Verification Test Set

Submission Summary (Full Text)

{0}

Page 1 of 6

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

A. 510(k) Number:
K060133

B. Purpose for Submission:
Premarket Notification 510(k) of intention to manufacture and market the Ischemia Albumin Cobalt Binding Test (ACB® Test) Assay Verification Set

C. Measurands:
Quality Control Material (assayed) for Albumin Cobalt Binding (ACB)

D. Type of Test:
Not Applicable

E. Applicant:
Inverness Medical Innovations, Inc.

F. Proprietary and Established Names:
Albumin Cobalt Binding (ACB) Test Assay Verification Set

G. Regulatory Information:
1. Regulation section:
21 CFR §862.1660; Single (Specified) Analyte Controls (assayed and unassayed)
2. Classification:
Class I
3. Product code:
JJX; Single (Specified) Analyte Controls (assayed and unassayed)

{1}

Page 2 of 6

4. Panel:
Chemistry (75)

H. Intended Use:

1. Intended use(s):
The Ischemia Albumin Cobalt Binding Test (ACB®) Assay Verification Set is intended for use in verifying accuracy of the ACB Test on the Roche Integra 700/800. It is recommended as a part of assay installation.

2. Indication(s) for use:
The Ischemia Albumin Cobalt Binding Test (ACB®) Assay Verification Set is intended for use in verifying accuracy of the ACB Test on the Roche Integra 700/800. It is recommended as a part of assay installation.

3. Special condition for use statement(s):
Not Applicable

4. Special instrument Requirements:
Roche Integra 700/800

I. Device Description:

The ACB® Test Assay Verification Set (AVS) is an assayed control material with established albumin cobalt binding capacity. It is a single use, non-sterile, in vitro diagnostic device consisting of twenty (20) single vial 0.5mL aliquots of serum based samples. The samples are assigned IMA values over the physiological range (40-180U/mL) and at points just above and just below the 85U/mL cut-off. Sample value range is such that an analytical correlation study can be evaluated by the user to determine whether their analyzer is accurately measuring IMA levels in clinical specimens. The AVS device is supplied in frozen liquid form and is stable up to the expiry date.

J. Substantial Equivalence Information:

1. Predicate device name(s):
Maine Standards Company VALIDATE CHEM 3 Calibration Verification Test Set.

2

{2}

Page 3 of 6

2. Predicate k number(s):

K012119

3. Comparison with predicate:

Comparison of Ischemia Albumin Cobalt Binding Test (ACB®) Assay Verification Set k060133 to the Predicate Maine Standards Company VALIDATE CHEM 3 Calibration Verification Test Set k012119

| Characteristics | Albumin Cobalt Binding Test (ACB®) Assay Verification Set k060133 | Maine Standards Company VALIDATE CHEM 3 Calibration Verification Test Set k012119 |
| --- | --- | --- |
| Intended Use | For use in verifying accuracy of the ACB Test on the Roche Integra 700/800. It is recommended as part of assay installation. For in vitro diagnostic use. | For in vitro diagnostic use in quantitatively verifying calibration, validating reportable ranges and determining linearity in automated, semi-automated and manual chemistry systems. |
| Matrix | EDTA and CoCl2 in off-clot human serum | Human serum protein base |
| Form | Frozen liquid | Liquid ready to use |
| Levels | 20 levels covering the physiological range | 6 including zero |
| Analytes | Single analyte representative of ischemia modified albumin | Multiple analytes of total protein, albumin, and cholesterol. |
| Analyzer | Roche Integra 700/800 | Automated, semi-automated and manual chemistry systems, including Roche Integra Systems |
| Vial Volume | 0.5mL per vial | 5.0mL of each level |
| Storage and Stability Unopened | Until expiry when frozen at -70°C or 4 weeks when frozen at -20°C | Until expiration at 2-8°C |
| Storage and Stability Opened | 12 hours when thawed and refrigerated at 2-8°C | Until expiration at 2-8°C |

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

None Stated

3

{3}

Page 4 of 6

L. Test Principle:

Not Applicable. This submission is for clearance of control material.

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

Not Applicable

b. Linearity/assay reportable range:

Not applicable. The assay is intended for qualitative use.

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

Traceability:

The Ischemia Assay Verification Set (AVS) is manufactured from commercially available pooled serum (off-the-clot), cobalt chloride and EDTA. Each material is tested individually for expected value. The final formulation is standardized for assay level internally using the Ischemia Technologies Albumin Cobalt Binding (ACB®) Test with known concentrations of cobalt chloride in serum and EDTA.

The serum is tested in duplicate using the ACB Test on the Cobas Mira Plus analyzer. Values for serum must fall within 60-100U/mL. Cobalt chloride and EDTA stock solutions are prepared in volume ranges from 0.5 μL to 10 μL and tested, in duplicate, using the ACB Test on a calibrated analyzer. The average ACB value is plotted against the volume of added cobalt chloride and EDTA and the curve fit must be linear with an R² value of ≥ 0.95.

The AVS formulation is evaluated by running the ACB Test, in duplicate, on increasing volumes of cobalt chloride in a serum and EDTA matrix using a calibrated analyzer. Average values are plotted against the volume of cobalt chloride and the curve generated must be linear with an R² value of ≥ 0.95. Initial target values are then confirmed internally prior to bulk formulation filling.

Each of the 20 AVS levels is dispensed from the bulk formulation in 0.5 mL aliquots and in appropriate dilution level into Micro

4

{4}

Page 5 of 6

Tubes with caps labeled with lot number and assay level (1-20). Product is boxed and placed in a -70° C freezer.

Controls and Calibrators:
There are no additional controls or calibrators used for AVS other than those cleared for use under the Albumin Cobalt Binding Test 510(k) s

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
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

{5}

Page 6 of 6

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.

6