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

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.

Device Description

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.

AI/ML Overview

The document describes modifications to an existing calibrator device, the Abbott Clinical Chemistry Multiconstituent Calibrator (MCC), by adding three new analytes: Iron, Lactate, and Magnesium. The study aims to demonstrate that the modified device is substantially equivalent to the original MCC (K981706) and that these modifications do not significantly change its safety and effectiveness.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria	Reported Device Performance
Value Assignment	For each analyte, system suitability (validity) is verified by calibrating and testing controls with pre-defined ranges. The mean value obtained for the reference standard solution must be within 5% from the known standard concentration.	The testing was performed independently for each analyte using one Abbott Architect c8000 System. System suitability was verified. NIST standards (and other specified reference materials) were used for applicable analytes. 20 replicates of each tested calibrator level and each respective standard solution were tested. Mean analyte values were calculated. The system was calibrated with the newly assigned mean analyte values and reference standard solutions were measured. Implicitly, the results met the 5% acceptance criterion, as the conclusion states the modified device is substantially equivalent to the predicate.
Shelf-life Stability	20 months from the date of manufacture.	Data to support a shelf-life stability of 20 months was established by accelerated stability studies on Architect c8000 Systems. The document states this was demonstrated by comparison with the predicate device.
Open-vial Stability	7 days when stored at 2 to 8 °C or 24 hours when stored at 15 to 30 °C. The stability claims of the previous formulation and traceability to the same reference methods were demonstrated to be substantially equivalent to the predicate device.	Open-vial stability was established by incubating opened calibrator vials at 30°C for 28 days with 3 calibrator lots. Results of the open vials (means of at least three replicates) were compared to those of freshly opened calibrator vials. Implicitly, the results supported the 7-day at 2-8°C and 24-hour at 15-30°C claims, as the conclusion states the modified device is substantially equivalent.
Substantial Equivalence	The modified device is substantially equivalent to the original Multiconstituent Calibrator (K981706). Modifications should not significantly change the safety and effectiveness of the device.	"The modified Abbott Clinical Chemistry Multiconstituent Calibrator (MCC) is substantially equivalent to the original Multiconstituent Calibrator as demonstrated by results obtained in the studies." The report explicitly states the modifications (addition of Iron, Lactate, Magnesium) did not significantly change the safety and effectiveness of the device.

2. Sample Sizes Used for the Test Set and Data Provenance

Value Assignment Test Set: For each analyte, 20 replicates of each tested calibrator level and each respective standard solution were tested.
Open-vial Stability Test Set: 3 calibrator lots were used. For each lot, results were assessed from "means of at least three replicates."
Shelf-life Stability Test Set: The document does not specify the exact sample size (number of lots or replicates) for the accelerated stability studies, only that they were performed on "Architect c8000 Systems."
Data Provenance: The document does not explicitly state the country of origin. The submitter is Abbott Laboratories in Irving, TX, USA. The studies appear to be prospective in nature, as they were conducted to demonstrate equivalence for the modified device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable in the conventional sense for this type of device. This device is a calibrator, and its "ground truth" or reference values are established through rigorous analytical methods (e.g., gravimetric, coulometric titration, IDMS) against recognized reference materials and standards (e.g., NIST SRMs). The expertise involved would be in analytical chemistry and metrology, not clinical interpretation by expert readers.

4. Adjudication Method for the Test Set

Not applicable. This study does not involve subjective interpretations requiring adjudication (like image analysis or clinical diagnosis). The "truth" is determined by objective analytical measurements compared to highly accurate reference standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a Class II in vitro diagnostic calibrator, not an AI-powered diagnostic device used by human readers for interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable Directly. While the "performance" of the calibrator itself is standalone (meaning, it functions mechanically and chemically as described), it's not an AI algorithm. The performance evaluation focuses on its analytical accuracy and stability when used with the Abbott ARCHITECT c8000 System.

7. The Type of Ground Truth Used

Reference Materials/Standards and Reference Methods:
- NIST Standards (National Institute of Standards and Technology Standard Reference Materials): Examples include NIST SRM 956 for Calcium and Magnesium, NIST SRM 967 and 914 for Creatinine, NIST SRM 965 for Glucose, NIST SRM 3126 for Iron, NIST SRM 909 for Urea Nitrogen and Uric Acid.
- ERM-DA470: For Albumin.
- Human Cholesterol (Abell-Kendall verification): For Cholesterol.
- Reagent grade lactate: For Lactic Acid.
- NIST 186-1/2186-I: For Phosphorus.
- NIST SRM 927: For Total Protein.
- ACS Grade Glycerol: For Triglyceride.
- Reference Methods: Such as Gravimetric, Coulometric Titration, Isotope Dilution Mass Spectrometry (IDMS), and Volumetric methods are used to establish the values traceable to these reference materials.

8. The Sample Size for the Training Set

Not applicable. This is a calibrator, not a machine learning model. There is no "training set" in the context of AI. The manufacturing and validation processes involve extensive quality control and verification, but not model training.

9. How the Ground Truth for the Training Set was Established

Not applicable. As a calibrator, its "true" values are established through metrologically sound procedures using primary reference materials and methods, as detailed in point 7.

Summary

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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 (972) 518-6711 Fax (972) 518-7479 Email: Linda.Morris@Abbott.com

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)

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
1. 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:

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 ofAlbumin, Calcium,Cholesterol, Creatinine,Glucose, Phosphorus, TotalProtein, Triglyceride Ureaand Uric Acid assays.	Same plus Iron, Lactate,and Magnesium
Component	Human serum matrixcontaining Albumin,Calcium, Cholesterol,Creatinine, Glucose,Phosphorus, Total Protein,Triglyceride Urea and UricAcid.	Same plus Iron, Lactate,and Magnesium
Storage	2 to 8° C	Same
Shelf-life Stability	20 months from date ofmanufacture	Same
Open-vial Stability	7 days when stored at 2 to 8°C or 24 hours when storedat 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(Abell-Kendallverification)	Volumetric
Creatinine	NIST SRM 967 and914	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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Page 2 -

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 (800) 638-2041 or (301) 796-7100 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

Page 1 of _ |

Regulation Number and Section

§ 862.1150 Calibrator.

(a)
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.)(b)
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.