MULTI-ANALYTE CHEMISTRY CALIBRATOR

K070207 · Pointe Scientific, Inc., · JIX · Apr 13, 2007 · Clinical Chemistry

Device Facts

• Record ID: K070207
• Device Name: MULTI-ANALYTE CHEMISTRY CALIBRATOR
• Applicant: Pointe Scientific, Inc.,
• Product Code: JIX · Clinical Chemistry
• Decision Date: Apr 13, 2007
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Indications for Use

The Chemistry calibrator is for use as a calibrator of Pointe Scientific, Inc. clinical chemistry assays. The analyte constituents, set-point values and instruments are provided in the product labeling. For prescription use. Use with automated and semi-automated chemistry analyzers

Device Story

Multi-Analyte Chemistry Calibrator; lyophilized human serum with diluent; contains constituents for Albumin, Bilirubin, BUN, Calcium, CO2, Chloride, Cholesterol, Creatinine, Glucose, Iron, Magnesium, Phosphorus, Total Protein, Triglycerides, and Uric Acid. Used in clinical laboratories to calibrate chemistry assays on automated/semi-automated analyzers. Values are lot-specific and provided in labeling. Human serum tested negative for HIV-1, HIV-2, HBsAg, and HCV. Provides standardized reference points for clinical chemistry testing; ensures accuracy of patient sample measurements.

Clinical Evidence

No clinical data. Bench testing only. Stability testing demonstrated 36-month shelf life at 2-8°C and 7-day open-vial stability (5 days for Bilirubin). Traceability established via NIST standard materials.

Technological Characteristics

Multi-analyte mixture; liquid or lyophilized form; intended for use with specific clinical chemistry analyzers as defined in product labeling. No specific materials or software algorithms described.

Indications for Use

Indicated for use as a calibrator for Pointe Scientific, Inc. clinical chemistry assays to establish set-point values for clinical laboratory testing.

Regulatory Classification

Identification

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

A. 510(k) Number:
k070207

B. Purpose for Submission:
New device

C. Measurand:
None - Submission is for calibrators

D. Type of Test:
Calibrators

E. Applicant:
Pointe Scientific Inc.

F. Proprietary and Established Names:
Multi-Analyte Chemistry Calibrator

G. Regulatory Information:
1. Regulation section:
21 CFR§ 862.1150 – Calibrator
2. Classification:
Class II
3. Product code:
JIX – Calibrator, Multi-analyte mixture
4. Panel:
Clinical Chemistry (75)

H. Intended Use:
1. Intended use(s):
See indications for use below.
2. Indication(s) for use:
The Chemistry calibrator is for use as a calibrator of Pointe Scientific, Inc. clinical chemistry assays. The analyte constituents, set-point values and instruments are provided in the product labeling.
3. Special conditions for use statement(s):
For prescription use.
4. Special instrument requirements:
Use with automated and semi-automated chemistry analyzers

I. Device Description:

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The Multi-analyte Chemistry calibrator is a product consists of lyophilized human serum and a diluent for reconstitution. The human serum contains calibrator constituents added to provide the defined assay values for Albumin, Total Bilirubin, Direct Bilirubin, BUN, Calcium, $\mathrm{CO}_{2}$, Chloride, Cholesterol, Creatinine, Glucose Hx, Glucose Ox, Iron, Magnesium, Phosphorus, Total Protein, Trig-GPO, and Uric Acid. The concentration of the calibrator components are lot specific and the values of the analytes are provided in the product labeling.

All human materials were tested by FDA approved methods and found to be negative for the presence of antibodies to HIV-1, HIV-2, HBsAg, and HCV.

## J. Substantial Equivalence Information:

1. Predicate device name(s):
Calibrator for Automated Systems

2. Predicate 510(k) number(s):
k990460

3. Comparison with predicates:

| Similarities | | |
| --- | --- | --- |
| Characteristics | Multi-Analyte Chemistry Calibrator (Proposed Device) | Roche Calibrator (C.f.a.s.) (Predicate Device) |
| Intended Use | The Chemistry calibrator is for use as a calibrator of Pointe Scientific, Inc. clinical chemistry assays. The analyte constituents, set-point values and instruments are provided in the product labeling | For use as a calibrator of clinical chemistry assays. This calibrator material is well suited for automated and semi-automated analytical procedures. |
| Composition | Lyophilized pooled serum with constituents added to obtain desired values | Lyophilized pooled serum with constituents added to obtain desired values |
| Stability | ●Unreconstituted chemistry calibrator is stable until the expiration date when stored at 2-8°C.
●Reconstituted chemistry calibrator is stable for seven days when stored at 2-8°C with the exception of Bilirubin, which is stable five days at 2-8°C.
●Store calibrator tightly capped and protected from light when not in use. | ●Stability of the lyophilized calibrator at 2-8°C: up to stated expiration date.
●Stability of the components in the reconstituted calibrator: at 2-8°C, 2 days. Exceptions: see below.
Total Bilirubin: at 2-8°C: 1 day.
Direct Bilirubin: at 2-8°C: 8 hours.
●Store calibrator tightly capped and protected from light when not in use. |

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| Levels | Single Level | Single Level |
| --- | --- | --- |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Constituents | Albumin, Total Bilirubin, Direct Bilirubin, BUN, Calcium, CO2, Chloride, Cholesterol, Creatinine, Glucose Hx, Glucose Ox, Iron, Magnesium, Phosphorus, Total Protein, Trig-GPO, Uric Acid | Acid Phosphatase, Alkaline Phosphatase, Alanine Aminotransferase, Alpha-Amylase, Aspartate Aminotransferase, Cholinesterase, creatine kinase, Gamma-Glutamyl transferase, Lactate Dehydrogenase, Lipase, Albumin, Total Bilirubin, Direct Bilirubin, Urea (BUN), Calcium, CO2, Chloride, Cholesterol, Creatinine, Glucose, Iron, Magnesium, Phosphorus, Total Protein, Triglyceride, Uric Acid, Sodium, Potassium, Bicarbonate, UIBC, LDI |

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

Not Applicable

# L. Test Principle:

Not Applicable

# M. Performance Characteristics (if/when applicable): 3

1. Analytical performance:

a. Precision/Reproducibility:

Not Applicable

b. Linearity/assay reportable range:

Not Applicable

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

Traceability

The sponsor provided the available NIST traceability information for constituents in the calibrator mixture. It is also available to the user upon request from the sponsor.

Value Assignment

The calibrator values are determined using Pointe Scientific, Inc. reagent methods and the analyzers listed in the value assignment table on the reverse side of the package insert. Determinations are performed under standardized conditions, utilizing known NIST standard materials. The commercial calibrator lot value is assigned with 3 runs, 10 values per run and using different lot numbers of the reagent. The final established value is obtained after calibrating against the previous calibrator lot, which is traceable to NIST

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material at $100 \pm 10\%$. The sponsor’s final acceptance criterion is that the newly manufactured calibrator values must recover within $100 \pm 10\%$ of a previous lot of calibrator.

## Stability

The sponsor conducted long-term storage stability and open-vial stability using 3 lots and 3 replicates per lot. Data analysis demonstrated the products stored at +2 to +8°C are stable for at least 36 months. Testing cycles are, 0 and 36 months. Open-vial testing of reconstituted calibrator demonstrated 7-day stability for all the constituents with the exception of Bilirubin for which the data indicate stability of 5 days at +2 to +8°C storage.

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. 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.