MULTICONSTITUENT CALIBRATOR

K103403 · Abbott Laboratories · JIX · Feb 4, 2011 · Clinical Chemistry

Device Facts

• Record ID: K103403
• Device Name: MULTICONSTITUENT CALIBRATOR
• Applicant: Abbott Laboratories
• Product Code: JIX · Clinical Chemistry
• Decision Date: Feb 4, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

For use in calibration of the Albumin, Calcium, Cholesterol, Creatinine, Glucose, Iron, Lactate, Magnesium, Phosphorus, Total Protein, Triglyceride, Urea and Uric Acid assays.

Device Story

Abbott Clinical Chemistry Multiconstituent Calibrator (MCC) is a liquid, human serum-based, ready-to-use calibration product. It contains 13 analytes: Albumin, Calcium, Cholesterol, Creatinine, Glucose, Iron, Lactate, Magnesium, Phosphorus, Total Protein, Triglyceride, Urea, and Uric Acid. Used in clinical laboratories to calibrate the Abbott ARCHITECT c8000 System. Value assignment for each analyte is performed by testing 20 replicates of the calibrator against NIST-traceable standards or reference materials using the ARCHITECT c8000. The system calculates mean analyte values based on absorbance and standard concentrations. Healthcare providers use the calibrated system to measure patient samples; accurate calibration ensures the reliability of clinical chemistry assay results, supporting diagnostic decision-making.

Clinical Evidence

Bench testing only. Stability was validated through accelerated studies confirming a 20-month shelf life. Open-vial stability (7 days at 2-8°C; 24 hours at 15-30°C) was confirmed by comparing results of opened vials to freshly opened vials across three lots. Value assignment accuracy was verified by testing 20 replicates against reference standards, with an acceptance criterion of ±5% from known standard concentrations.

Technological Characteristics

Liquid, human serum-based matrix. Analyte concentrations assigned via Abbott ARCHITECT c8000 System using NIST-traceable reference materials (e.g., NIST SRM 956, 967, 965, 3126, 927, 909). Storage: 2-8°C. Shelf-life: 20 months. Open-vial stability: 7 days at 2-8°C or 24 hours at 15-30°C.

Indications for Use

Indicated for use as an in vitro diagnostic calibration serum in clinical chemistry assays on the Abbott ARCHITECT c8000 System. Contains 13 analytes in a liquid human serum-based matrix at 2 concentration levels.

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.

Predicate Devices

• Abbott Clinical Chemistry MCC (K981706)

Submission Summary (Full Text)

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# 510(k) Summary

#### Submitter's Name/Address

Abbott Laboratories 1921 Hurd Drive Irving, TX 75038

Contact Person Linda Morris Senior Regulatory Specialist, MS 2-11 Regulatory Affairs [phone] Fax [phone] Email: [e-mail]

Date of Preparation of this Summary:

Device Trade or Proprietary Name:

January 14, 2011

Abbott Clinical Chemistry Multiconstituent Calibrator

Device Common/Usual Name or Classification Name:

Classification Number/Class:

21 CFR 862.1150/ Class II

Multiconstituent Calibrator (MCC)

(Calibrator, Multi-Analyte Mixture) JIX

### Product Code:

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: (k)103403______________________________________________________________________________________________________________________________________

# Device Description:

# Original { Abbott Clinical Chemistry MCC (k981706)

A multi-Analyte Calibrator - human serum based, liquid ready-to-use calibrator containing Albumin, Calcium, Cholesterol, Creatinine, Glucose, Phosphorus, Total Protein, Triglyceride, Urea and Uric Acid.

# Modified Abbott Clinical Chemistry MCC (k103403)

A multi-Analyte Calibrator - human serum based, liquid ready-to-use calibrator containing Albumin, Calcium, Cholesterol, Creatinine, Glucose, Iron, Lactate, Magnesium, Phosphorus, Total Protein, Triglyceride, Urea and Uric Acid.

3

FEB - 4 2011

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# Description of modifications:

The modified Abbott Clinical Chemistry Multiconstituent Calibrator is substantially equivalent to the original Multiconstituent Calibrator (K981706). The modifications consisted of certification of the following new analytes:

- l. Iron
- 2. Lactate
- · 3. Magnesium

These modifications did not significantly change the safety and effectiveness of the device as demonstrated in the Performance Characteristics Summary.

### Intended Use:

For use in calibration of the Albumin, Calcium, Cholesterol, Creatinine, Glucose, Iron, Lactate, Magnesium, Phosphorus, Total Protein, Triglyceride, Urea and Uric Acid assays.

# Indications for use:

This is an in vitro diagnostic product intended for use as a calibration serum in clinical chemistry assays. The MCC contains 13 analytes in a liquid human serum based matrix. The concentrations and activities are suitable for calibration of the Abbott ARCHITECT c8000 System. Constituent concentrations are available at 2 levels.

# Predicate Device Description: MCC (k981706)

- Human serum based, liquid ready-to-use .
- Containing Albumin, Calcium, Cholesterol, Creatinine, Glucose, Phosphorus, . Total Protein, Triglyceride, Urea and Uric Acid
- Shelf-life of 20 months demonstrated by real time testing .

# Modified MCC Device:

- Human serum based, liquid ready-to-use. .
- Containing Albumin, Calcium, Cholesterol, Creatinine, Glucose, Iron, Lactate, . Magnesium, Phosphorus, Total Protein, Triglyceride, Urea and Uric Acid
- Shelf-life of 20 months was demonstrated by comparison with predicate using . accelerated studies.
- The modifications are the addition of Iron, Lactate and Magnesium (at . physiological levels) to the formulation.
- These modifications did not significantly change the safety and effectiveness of . The device. The stability data confirms that the stability of the new formulation the device. The stability claims of the previous formulation and traccability to connorms to the blackly the same reference methods has been demonstrated to be substantially equivalent to the predicate device.

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In determining substantial equivalence, a direct comparison of new and predicate device was performed, refer to table below.

| Attributes | Predicate MCC (k)981706 | Modified MCC (k)103403 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|
| Intended Use | For use in the calibration of<br>Albumin, Calcium,<br>Cholesterol, Creatinine,<br>Glucose, Phosphorus, Total<br>Protein, Triglyceride Urea<br>and Uric Acid assays. | Same plus Iron, Lactate,<br>and Magnesium |
| Component | Human serum matrix<br>containing Albumin,<br>Calcium, Cholesterol,<br>Creatinine, Glucose,<br>Phosphorus, Total Protein,<br>Triglyceride Urea and Uric<br>Acid. | Same plus Iron, Lactate,<br>and Magnesium |
| Storage | 2 to 8° C | Same |
| Shelf-life Stability | 20 months from date of<br>manufacture | Same |
| Open-vial Stability | 7 days when stored at 2 to 8<br>°C or 24 hours when stored<br>at 15 to 30 °C | Same |

Value assignment and Traceability:

Value assignment is performed as follows:

- The testing is performed independently for each of the analytes, using one Abbott . Architect c8000 System.
- For each analyte, system suitability (validity) is verified by calibrating and testing . controls with pre-defined ranges.
- NIST standards are used for applicable analytes (refer to table on the next page . for a list of all standards used).
- The standards may need to be weighed, dissolved and/or diluted to prepare a . solution of appropriate concentration for the value assignment.
- 20 replicates of each tested calibrator level and of each respective standard . solution are tested.
- The mean analyte values are calculated using the concentration of the standard . The mount and the absorbance values of the standard and the tested calibrator.
- Solution analyte values are verified by calibrating the system with the newly . I he mean andryte varant, and measuring the reference standard solutions.
- Acceptance criterion: the mean value obtained for the reference standard solution . must be within 5% from the known standard concentration.

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| Analyte | Reference Material | Reference Method |
|---------------|------------------------------------------------------|-----------------------|
| Albumin | ERM-DA470 | Gravimetric |
| Calcium | NIST SRM 956 | Coulometric Titration |
| Cholesterol | Human Cholesterol<br>(Abell-Kendall<br>verification) | Volumetric |
| Creatinine | NIST SRM 967 and<br>914 | IDMS |
| Glucose | NIST SRM 965 | IDMS |
| Iron | NIST SRM 3126 | Gravimetric |
| Lactic Acid | Reagent grade lactate | Gravimetric |
| Magnesium | NIST SRM 956 | IDMS |
| Phosphorus | NIST 186-1/2186-I | Gravimetric |
| Total Protein | NIST SRM 927 | Gravimetric |
| Triglyceride | ACS Grade Glycerol | Gravimetric |
| Urea Nitrogen | NIST SRM 909 | IDMS |
| Uric Acid | NIST SRM 909 | IDMS |

Standardization/ Traceability information:

# Stability:

The expiration date claim is 20 months from product dispensing. Open vial stability claim is 7 days at 2-8 °C and 24 hours at room temperature (15-30 °C).

Data to support shelf-life stability of 20 months was established by accelerated stability studies on Architect c8000 Systems.

Open vial stability was established by incubating opened calibrator vials at 30°C for 28 Open vial stability was colloried i with 3 calibrator lots. Results of the open vials means of at least three replicates) were compared to those of freshly opened calibrator vials.

# Conclusion:

The modified Abbott Clinical Chemistry Multiconstituent Calibrator (MCC) is The modified Abbott Chineal Chemistry Mialiconstituent Calibrator Calibrator as demonstrated by results obtained in the studies.

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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

# FEB 0 4 2011

Abbott Laboratories c/o Linda Morris Senior Regulatory Specialist 1921 Hurd Drive Irving, TX. 75038, USA

Re: k103403 Trade/Device Name: Abbott Clinical Chemistry Multiconstituent Calibrator Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator, Multi-Analyte Mixture Regulatory Class: Class II Product Code: JIX Dated: January 21, 2011 Received: January 21, 2011

Dear Ms. Morris

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce. prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFF) Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation (21 CFR Parts 801 and 5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

G.C.

Courtney Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use Form

#### 510(k) Number (if known): (k)103403

Device Name: Abbott Clinical Chemistry Multiconstituent Calibrator

#### Indications for Use:

The Abbott Clinical Chemistry Multiconstituent Calibrator is an in vitro diagnostic product intended for use as a calibration serum in clinical chemistry assays. The MCC contains 13 analytes in a liquid human serum based matrix. The concentrations and activities are suitable for calibration of the Abbott ARCHITECT c8000 System. Constituent concentrations are available at 2 levels.

Prescription Use x (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

· (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign Off

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K103403

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