Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details a standard clinical chemistry assay based on a chemical reaction and spectrophotometric measurement, with no mention of AI or ML.

Therapeutic

No
The device is an in vitro diagnostic assay used for the quantitation of calcium, which aids in diagnosis and treatment monitoring, but it does not directly treat a disease or condition.

Diagnostic

Yes

The device aids in the diagnosis and treatment of various medical conditions by quantifying calcium levels, which is a diagnostic function.

SaMD (Software as a Medical Device)

No

The device is a clinical chemistry assay that uses a chemical reaction and measures color change at a specific wavelength (660 nm) on the ARCHITECT c System. This involves physical reagents and hardware (the ARCHITECT c System) to perform the measurement, not just software.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use explicitly states that the assay is used for the "quantitation of calcium in human serum, plasma, or urine." These are biological samples taken from the human body.
Purpose: The intended use also states that the measurements are used "in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany." This indicates the device is used for medical purposes related to diagnosing and monitoring health conditions.
Methodology: The device description details a chemical reaction (Arsenazo III dye reacting with calcium) that occurs in vitro (outside the living body) to measure the analyte.
Performance Studies: The summary of performance studies describes testing conducted on biological samples (serum, plasma, urine) to evaluate the device's accuracy, precision, and other performance characteristics relevant to diagnostic use.

All these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Calcium2 assay is used for the quantitation of calcium in human serum, plasma, or urine on the ARCHITECT c System.

Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

Product codes (comma separated list FDA assigned to the subject device)

CJY

Device Description

The Calcium2 assay is an automated clinical chemistry assay. Arsenazo III dye reacts with calcium in an acid solution to form a blue-purplex. The color developed is measured at 660 nm and is proportional to the calcium concentration in the sample.

Methodology: Arsenazo III

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

All performance characteristics were obtained using the ARCHITECT c8000 System.

Reportable Interval - Serum/Plasma

Analytical Measuring Interval (AMI): 2.0 – 24.0 mg/dL
Reportable Interval: 0.2 – 24.0 mg/dL

Reportable Interval – Urine

Analytical Measuring Interval (AMI): 2.0 – 24.0 mg/dL
Extended Measuring Interval (EMI): 24.0 – 96.0 mg/dL
Reportable Interval: 0.2 – 96.0 mg/dL

Within-Laboratory Precision - Serum

1. Within-Laboratory Precision (20-Day)

Study based on CLSI EP05-A3.
Testing conducted using 3 lots of Calcium2 reagent, 3 lots of Consolidated Chemistry Calibrator (ConCC), 1 lot of commercially available controls, and 3 instruments.
Two controls and 3 human serum panels were tested in 2 replicates, twice per day on 20 days on 3 reagent lot/calibrator lot/instrument combinations.
Key Results (representative combination):
- Control Level 1 (Mean 9.5 mg/dL): Within-Run SD 0.07, %CV 0.8; Within-Laboratory SD 0.07 (0.07 – 0.08), %CV 0.8 (0.8 – 0.9)
- Control Level 2 (Mean 12.7 mg/dL): Within-Run SD 0.08, %CV 0.7; Within-Laboratory SD 0.09 (0.08 – 0.11), %CV 0.7 (0.6 – 0.9)
- Panel A (Mean 3.3 mg/dL): Within-Run SD 0.05, %CV 1.5; Within-Laboratory SD 0.05 (0.05 – 0.07), %CV 1.5 (1.5 – 2.3)
- Panel B (Mean 6.3 mg/dL): Within-Run SD 0.05, %CV 0.8; Within-Laboratory SD 0.07 (0.05 – 0.08), %CV 1.1 (0.8 – 1.3)
- Panel C (Mean 22.5 mg/dL): Within-Run SD 0.14, %CV 0.6; Within-Laboratory SD 0.20 (0.19 – 0.20), %CV 0.9 (0.9 – 0.9)

2. System Reproducibility

Study based on CLSI EP05-A3.
Testing conducted using 1 lot of Calcium2 reagent, 1 lot of ConCC, 1 lot of commercially available controls, and 3 instruments.
Each instrument operated by a different technician, each preparing an individual sample set.
Two controls and 3 human serum panels were tested in 3 replicates at 2 separate times per day on 5 different days.
Key Results:
- Control Level 1 (n=90, Mean 9.4 mg/dL): Repeatability SD 0.09, %CV 0.9; Within-Laboratory SD 0.10, %CV 1.1; Reproducibility SD 0.13, %CV 1.4
- Control Level 2 (n=90, Mean 12.5 mg/dL): Repeatability SD 0.10, %CV 0.8; Within-Laboratory SD 0.10, %CV 0.8; Reproducibility SD 0.12, %CV 1.0
- Panel A (n=90, Mean 3.3 mg/dL): Repeatability SD 0.05, %CV 1.5; Within-Laboratory SD 0.05, %CV 1.5; Reproducibility SD 0.08, %CV 2.6
- Panel B (n=90, Mean 6.3 mg/dL): Repeatability SD 0.08, %CV 1.2; Within-Laboratory SD 0.08, %CV 1.2; Reproducibility SD 0.11, %CV 1.7
- Panel C (n=90, Mean 22.2 mg/dL): Repeatability SD 0.18, %CV 0.8; Within-Laboratory SD 0.19, %CV 0.9; Reproducibility SD 0.19, %CV 0.9

Within-Laboratory Precision - Urine

1. Within-Laboratory Precision (20-Day)

Study based on CLSI EP05-A3.
Testing conducted using 3 lots of Calcium2 reagent, 3 lots of ConCC, 1 lot of commercially available controls, and 3 instruments.
Two controls and 3 human urine panels were tested in 2 replicates, twice per day on 20 days on 3 reagent lot/calibrator lot/instrument combinations.
Key Results (representative combination):
- Control Level 1 (Mean 6.7 mg/dL): Within-Run SD 0.07, %CV 1.0; Within-Laboratory SD 0.08 (0.05 - 0.08), %CV 1.1 (0.8 - 1.2)
- Control Level 2 (Mean 9.6 mg/dL): Within-Run SD 0.08, %CV 0.9; Within-Laboratory SD 0.10 (0.06 - 0.10), %CV 1.0 (0.7 - 1.0)
- Panel A (Mean 3.2 mg/dL): Within-Run SD 0.06, %CV 1.9; Within-Laboratory SD 0.08 (0.04 - 0.08), %CV 2.5 (1.4 - 2.5)
- Panel B (Mean 14.2 mg/dL): Within-Run SD 0.12, %CV 0.8; Within-Laboratory SD 0.12 (0.10 - 0.12), %CV 0.9 (0.7 - 0.9)
- Panel C (Mean 23.1 mg/dL): Within-Run SD 0.14, %CV 0.6; Within-Laboratory SD 0.17 (0.14 - 0.17), %CV 0.7 (0.6 - 0.8)

2. System Reproducibility

Study based on CLSI EP05-A3.
Testing conducted using 1 lot of Calcium2 reagent, 1 lot of ConCC, 1 lot of commercially available controls, and 3 instruments.
Each instrument operated by a different technician, each preparing an individual sample set.
Two controls and 3 human urine panels were tested in 3 replicates at 2 separate times per day on 5 different days.
Key Results:
- Control Level 1 (n=90, Mean 6.9 mg/dL): Repeatability SD 0.06, %CV 0.9; Within-Laboratory SD 0.07, %CV 1.0; Reproducibility SD 0.10, %CV 1.4
- Control Level 2 (n=90, Mean 9.9 mg/dL): Repeatability SD 0.09, %CV 0.9; Within-Laboratory SD 0.09, %CV 0.9; Reproducibility SD 0.11, %CV 1.1
- Panel A (n=90, Mean 3.1 mg/dL): Repeatability SD 0.06, %CV 1.8; Within-Laboratory SD 0.07, %CV 2.2; Reproducibility SD 0.09, %CV 2.9
- Panel B (n=90, Mean 14.2 mg/dL): Repeatability SD 0.11, %CV 0.8; Within-Laboratory SD 0.12, %CV 0.8; Reproducibility SD 0.15, %CV 1.1
- Panel C (n=90, Mean 23.1 mg/dL): Repeatability SD 0.18, %CV 0.8; Within-Laboratory SD 0.18, %CV 0.8; Reproducibility SD 0.23, %CV 1.0

Accuracy

Study performed to estimate bias relative to NIST SRM 956d Level 1 and Level 2.
Testing conducted using 2 concentrations of the standard across 3 lots of Calcium2 reagent, 2 lots of ConCC, and 1 instrument.
Result: Bias ranged from -3.7% to -0.6%.

Lower Limits of Measurement - Serum

Study based on CLSI EP17-A2.
Testing conducted using 3 lots of Calcium2 reagent on each of 2 instruments over 3 days.
Results:
- LoB: 0.1 mg/dL
- LoD: 0.2 mg/dL
- LoQ: 0.4 mg/dL

Lower Limits of Measurement - Urine

Study based on CLSI EP17-A2.
Testing conducted using 3 lots of Calcium2 reagent on each of 2 instruments over 3 days.
Results:
- LoB: 0.1 mg/dL
- LoD: 0.2 mg/dL
- LoQ: 0.5 mg/dL

Linearity - Serum

Study based on CLSI EP06 2nd ed.
Result: Assay demonstrated to be linear from 2.0 to 24.0 mg/dL.

Linearity - Urine

Study based on CLSI EP06 2nd ed.
Result: Assay demonstrated to be linear from 2.0 to 24.0 mg/dL.

Potentially Interfering Endogenous and Exogenous Substances - Serum

Potentially Interfering Endogenous Substances

Study based on CLSI EP07 3rd ed.
Each substance tested at 2 levels of the analyte (approximately 9 mg/dL and 12 mg/dL).
No significant interference (within ± 5%) observed at specified concentrations for Bilirubin (conjugated, 40 mg/dL), Bilirubin (unconjugated, 40 mg/dL), Hemoglobin (1,000 mg/dL), Total protein (15 g/dL), Triglycerides (1500 mg/dL).

Potentially Interfering Exogenous Substances

No significant interference (within ± 5%) observed at specified concentrations for numerous substances including Acetaminophen, Acetylcysteine, Acetylsalicylic acid, Ampicillin-Na, Ascorbic acid, Cefoxitin, Cyclosporine, Doxycycline, Ibuprofen, Levodopa, Magnesium sulfate, Methyldopa, Metronidazole, Phenylbutazone, Rifampicin, Sodium heparin, Theophylline.
Interference beyond ± 5% observed for Ca-dobesilate at 60 mg/L (Analyte Level 9 mg/dL) with 6% interference (95% CI: 5%, 6%).

Potentially Interfering Endogenous and Exogenous Substances - Urine

Potentially Interfering Endogenous Substances

Study based on CLSI EP07 3rd ed.
Each substance tested at 2 levels of the analyte (approximately 8 mg/dL and 16 mg/dL).
No significant interference (within ± 5%) observed at specified concentrations for Ascorbate (100 mg/dL), Glucose (500 mg/dL), Magnesium sulfate (50 mg/dL), Total protein (30 mg/dL), Sample pH (2.5 to 6.0), Urea (5000 mg/dL), Uric acid (92 mg/dL).

Potentially Interfering Exogenous Substances

No significant interference (within ± 5%) observed at specified concentrations for Acetaminophen, Acetic acid (8.5N), Boric acid, Hydrochloric acid (6N), Ibuprofen, Nitric acid (6N).
Interference beyond ± 5% observed for Acetic acid (8.5N) at 6.25 mL/dL (Analyte Level 8 mg/dL) with -7% interference (95% CI: -8%, -6%).

Method Comparison - Serum

Study based on CLSI EP09c 3rd ed. using Passing-Bablok regression.
Compared Calcium2 assay to comparator Calcium assay on ARCHITECT c8000 System.
Sample Size: 120
Key Results: Correlation Coefficient 1.00, Intercept -0.1, Slope 1.02, Concentration Range 2.3–21.1 mg/dL.

Method Comparison - Urine

Study based on CLSI EP09c 3rd ed. using Passing-Bablok regression.
Compared Calcium2 assay to comparator Calcium assay on ARCHITECT c8000 System.
Sample Size: 112
Key Results: Correlation Coefficient 1.00, Intercept 0.1, Slope 0.96, Concentration Range 2.1–22.7 mg/dL.

Tube Type Equivalence - Serum

Study evaluated suitability of blood collection tube types from 78 donors.
Acceptable blood collection tube types: Serum tubes, Serum separator tubes, Lithium heparin tubes, Lithium heparin separator tubes, Sodium heparin tubes.

Dilution Verification - Urine

Study based on CLSI EP34 1st ed.
Evaluated recovery of Calcium2 automated and manual dilution.
Five samples prepared with calcium concentrations within EMI (26, 41, 56, 71, 85 mg/dL).
Automated and manual dilution recovery acceptable (within or equal to 100% ± 10%).
Automated dilution reproducibility: imprecision ≤ 5 %CV.
Manual dilution reproducibility: imprecision ≤ 6 %CV.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K062855

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 862.1145 Calcium test system.

(a)
Identification. A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).(b)
Classification. Class II.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 10, 2025

Abbott Ireland Cherie Lipowsky Regulatory Affairs Manager Diagnostic Divison Lisnamuck, Longford Ireland

Re: K244042

Trade/Device Name: Calcium2 Regulation Number: 21 CFR 862.1145 Regulation Name: Calcium test system Regulatory Class: Class II Product Code: CJY Dated: December 30, 2024 Received: December 30, 2024

Dear Cherie Lipowsky:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Paula V. Caposino -S

Paula Caposino, Ph.D. Deputy Division Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K244042

Device Name

Calcium2

Indications for Use (Describe)

The Calcium2 assay is used for the quantitation of calcium in human serum, plasma, or urine on the ARCHITECT c System.

Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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Administrative Documentation - 510(k) Summary (Summary of Safety and Effectiveness)

This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Federal Food, Drug, and Cosmetic Act, and 21 CFR §807.92.

510(k) Number: K244042

I. Applicant Name

Abbott Ireland Diagnostics Division Lisnamuck, Longford, Co. Longford, Ireland

Primary contact person for all communications:

Cherie Lipowsky, Regulatory Affairs Manager Abbott Diagnostics Division Phone: (224) 668-1435 Fax: (224) 667-4836 Email: cherie.lipowsky(@abbott.com

Secondary contact person for all communications:

Jacob Richards, Associate Director of Regulatory Affairs Abbott Diagnostics Division Phone: (224) 668-8852 Fax: (224) 667-4836 Email: jacob.richards(@abbott.com

Date Summary Prepared: February 07, 2025

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II. Subject Device

Trade Name: Calcium2

Device Classification: Class II Classification Name: Calcium Test System Regulation Number: 21 CFR §862.1145 Product Code: CJY

III. Predicate Device

Abbott Clinical Chemistry Architect/Aeroset Calcium; K062855

IV. Description of Device

A. Principles of the Procedure

The Calcium2 assay is an automated clinical chemistry assay. Arsenazo III dye reacts with calcium in an acid solution to form a blue-purplex. The color developed is measured at 660 nm and is proportional to the calcium concentration in the sample.

Methodology: Arsenazo III

B. Reagent

The configurations of the Calcium2 reagent kits are described below.

	List Number
	04S9120	04S9130
Tests per cartridge	300	1,350
Number of cartridges per kit	4	4
Tests per kit	1,200	5,400
Reagent 1 (R1)	22.9 mL	91.8 mL

R1: Active ingredient: Arsenazo III 0.932 g/L. Preservative: sodium azide.

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V. Intended Use of the Device

The Calcium2 assay is used for the quantitation of calcium in human serum, plasma, or urine on the ARCHITECT c System.

Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

VI. Comparison of Technological Characteristics

The Calcium2 assay (subject device) is an automated clinical chemistry assay for the quantitation of calcium in human serum, plasma, or urine on the ARCHITECT c System.

The similarities and differences between the subject device and the predicate device are presented in the Assay Similarities (Table VI.1) and Assay Differences (Table VI.2), respectively.

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Table VI.1

Assay Similarities

| Characteristics | Subject Device
Calcium2 (List Number [LN] 04S91)
(K244042) | Predicate Device
Abbott Clinical Chemistry Architect/Aeroset
Calcium (LN 3L79)
(K062855) |
|-----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use and
Indications for Use | The Calcium2 assay is used for the quantitation of
calcium in human serum, plasma, or urine on the
ARCHITECT c System.
Calcium measurements are used in the diagnosis and
treatment of parathyroid disease, a variety of bone
diseases, chronic renal disease and tetany (intermittent
muscular contractions or spasms). | The Calcium assay is used for the quantitation of calcium in
human serum, plasma, or urine.
Calcium measurements are used in the diagnosis and
treatment of parathyroid disease, a variety of bone diseases,
chronic renal disease and tetany (intermittent muscular
contractions or spasms). |
| Methodology | Arsenazo III | Same |
| Specimen Type | Human serum, plasma, or urine | Same |
| Assay Principle/
Principle of
Procedure | The Calcium2 assay is an automated clinical chemistry
assay. Arsenazo III dye reacts with calcium in an acid
solution to form a blue-purple complex. The color
developed is measured at 660 nm and is proportional to
the calcium concentration in the sample. | Same |
| Use of Calibrators | Yes | Same |
| Use of Controls | Yes | Same |
| Traceability | NIST SRM 956 | Same |
| Characteristics | Subject Device
Calcium2 (List Number [LN] 04S91)
(K244042) | Predicate Device
Abbott Clinical Chemistry Architect/Aeroset
Calcium (LN 3L79)
(K062855) |
| Platform | ARCHITECT c8000 System | AEROSET and ARCHITECT c8000 System |
| Assay Range | Serum/Plasma:
Analytical Measuring Interval (AMI):
2.0–24.0 mg/dL
Reportable Interval:
0.2–24.0 mg/dL
Urine:
Analytical Measuring Interval (AMI):
2.0–24.0 mg/dL
Extended Measuring Interval (EMI):
24.0-96.0 mg/dL | Serum/Plasma/Urine:
2.0-24.0 mg/dL |
| | Reportable Interval:
0.2–96.0 mg/dL | |
| Lower Limits of
Measurement | Serum/Plasma:
Limit of Blank (LoB): 0.1 mg/dL
Limit of Detection (LoD): 0.2 mg/dL
Limit of Quantitation (LoQ): 0.4 mg/dL
Urine:
LoB: 0.1 mg/dL
LoD: 0.2 mg/dL
LoQ: 0.5 mg/dL | Serum/Urine:
LoD: 0.5 mg/dL
LoQ: 1.0 mg/dL |

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Table VI.2

Assay Differences

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VII. Summary of Nonclinical Performance

All performance characteristics were obtained using the ARCHITECT c8000 System.

A. Reportable Interval - Serum/Plasma

Based on the limit of quantitation (LoQ) and the limit of detection (LoD), precision, and linearity, the ranges over which results can be reported are provided below.

	mg/dL
Analytical Measuring Interval (AMI)a	2.0 – 24.0
Reportable Intervalb	0.2 – 24.0

a AMI: The AMI is determined by the range of values in mg/dL that demonstrated acceptable performance for linearity, imprecision, and bias.

b The reportable interval extends from the LoD to the upper limit of the AMI.

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B. Reportable Interval – Urine

Based on the limit of quantitation (LoQ) and the limit of detection (LoD), precision, and linearity, the ranges over which results can be reported are provided below.

	mg/dL
Analytical Measuring Interval (AMI)a	2.0 – 24.0
Extended Measuring Interval (EMI)b	24.0 – 96.0
Reportable Intervalc	0.2 – 96.0

ª AMI: The AMI is determined by the range of values in mg/dL that demonstrated acceptable performance for linearity, imprecision, and bias.

b EMI: The EMI extends from the upper limit of quantitation (ULoQ) to the ULoQ × dilution factor.

° The reportable interval extends from the LoD to the upper limit of the EMI.

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C. Within-Laboratory Precision - Serum

1. Within-Laboratory Precision (20-Day)

A study was performed based on guidance from CLSI EP05-A3. * Testing was conducted using 3 lots of the Calcium2 reagent, 3 lots of the Consolidated Chemistry Calibrator (ConCC), and 1 lot of commercially available controls and 3 instruments. Two controls and 3 human serum panels were tested in 2 replicates, twice per day on 20 days on 3 reagent lot/calibrator lot/instrument combinations, where a unique reagent lot and a unique calibrator lot is paired with 1 instrument. The performance from a representative combination is shown in the following table.

| Sample | n | Mean
(mg/dL) | Within-Run
(Repeatability) | | Within-Laboratorya | |
|-----------------|----|-----------------|-------------------------------|-----|-----------------------|--------------------|
| | | | SD | %CV | SD
(Rangeb) | %CV
(Rangeb) |
| Control Level 1 | 80 | 9.5 | 0.07 | 0.8 | 0.07
(0.07 – 0.08) | 0.8
(0.8 – 0.9) |
| Control Level 2 | 80 | 12.7 | 0.08 | 0.7 | 0.09
(0.08 – 0.11) | 0.7
(0.6 – 0.9) |
| Panel A | 80 | 3.3 | 0.05 | 1.5 | 0.05
(0.05 – 0.07) | 1.5
(1.5 – 2.3) |
| Panel B | 80 | 6.3 | 0.05 | 0.8 | 0.07
(0.05 – 0.08) | 1.1
(0.8 – 1.3) |
| Panel C | 80 | 22.5 | 0.14 | 0.6 | 0.20
(0.19 – 0.20) | 0.9
(0.9 – 0.9) |

a Includes within-run, between-run, and between-day variability.

b Minimum and maximum SD or %CV across the 3 reagent lot/calibrator lot/instrument combinations.

Clinical and Laboratory Standards Institute (CLSI). Evaluation of Quantitative Measurement Procedures; Approved Guideline—Third Edition. CLSI Document EP05-A3. Wayne, PA: CLSI; 2014.

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2. System Reproducibility

A study was performed based on guidance from the CLSI document EP05-A3. * Testing was conducted using 1 lot of the Calcium2 reagent, 1 lot of the ConCC, 1 lot of commercially available controls, and 3 instruments. Each instrument was operated by a different technician, and each technician prepared an individual sample set. Two controls and 3 human serum panels were tested in 3 replicates at 2 separate times per day on 5 different days.

| Sample | n | Mean
(mg/dL) | Repeatability | | Within-
Laboratorya | | Reproducibilityb | |
|--------------------|----|-----------------|---------------|-----|------------------------|-----|------------------|-----|
| | | | SD | %CV | SD | %CV | SD | %CV |
| Control
Level 1 | 90 | 9.4 | 0.09 | 0.9 | 0.10 | 1.1 | 0.13 | 1.4 |
| Control
Level 2 | 90 | 12.5 | 0.10 | 0.8 | 0.10 | 0.8 | 0.12 | 1.0 |
| Panel A | 90 | 3.3 | 0.05 | 1.5 | 0.05 | 1.5 | 0.08 | 2.6 |
| Panel B | 90 | 6.3 | 0.08 | 1.2 | 0.08 | 1.2 | 0.11 | 1.7 |
| Panel C | 90 | 22.2 | 0.18 | 0.8 | 0.19 | 0.9 | 0.19 | 0.9 |

ª Includes repeatability (within-run), between-run, and between-day variability.

b Includes repeatability (within-run), between-day, and between-instrument variability.

Clinical and Laboratory Standards Institute (CLSI). Evaluation of Quantitative Measurement Procedures; Approved Guideline-Third Edition. CLSI Document EP05-A3. Wayne, PA: CLSI; 2014.

13

D. Within-Laboratory Precision - Urine

1. Within-Laboratory Precision (20-Day)

A study was performed based on guidance from CLSI EP05-A3. * Testing was conducted using 3 lots of the Calcium2 reagent, 3 lots of the ConCC, and 1 lot of commercially available controls and 3 instruments. Two controls and 3 human urine panels were tested in 2 replicates, twice per day on 20 days on 3 reagent lot/calibrator lot/instrument combinations, where a unique reagent lot and a unique calibrator lot is paired with 1 instrument. The performance from a representative combination is shown in the following table.

| | | | Within-Run
(Repeatability) | | | Within-Laboratorya | |
|--------------------|----|-----------------|-------------------------------|-----|-----------------------|--------------------|--|
| | | Mean
(mg/dL) | SD | %CV | SD
(Rangeb) | %CV
(Rangeb) | |
| Sample | n | | | | | | |
| Control
Level 1 | 80 | 6.7 | 0.07 | 1.0 | 0.08
(0.05 - 0.08) | 1.1
(0.8 - 1.2) | |
| Control
Level 2 | 80 | 9.6 | 0.08 | 0.9 | 0.10
(0.06 - 0.10) | 1.0
(0.7 - 1.0) | |
| Panel A | 80 | 3.2 | 0.06 | 1.9 | 0.08
(0.04 - 0.08) | 2.5
(1.4 - 2.5) | |
| Panel B | 80 | 14.2 | 0.12 | 0.8 | 0.12
(0.10 - 0.12) | 0.9
(0.7 - 0.9) | |
| Panel C | 80 | 23.1 | 0.14 | 0.6 | 0.17
(0.14 - 0.17) | 0.7
(0.6 - 0.8) | |

ª Includes within-run, between-run, and between-day variability.

b Minimum and maximum SD or %CV across the 3 reagent lot/calibrator lot/instrument combinations.

Clinical and Laboratory Standards Institute (CLSI). Evaluation of Quantitative Measurement Procedures; Approved Guideline—Third Edition. CLSI Document EP05-A3. Wayne, PA: CLSI; 2014.

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2. System Reproducibility

A study was performed based on guidance from the CLSI document EP05-A3. * Testing was conducted using 1 lot of the Calcium2 reagent, 1 lot of the ConCC, 1 lot of commercially available controls, and 3 instruments. Each instrument was operated by a different technician, and each technician prepared an individual sample set. Two controls and 3 human urine panels were tested in 3 replicates at 2 separate times per day on 5 different days.

| | | Mean | Repeatability | | Within-
Laboratoryª | | Reproducibilityb | |
|--------------------|----|---------|---------------|-----|------------------------|-----|------------------|-----|
| Sample | n | (mg/dL) | SD | %CV | SD | %CV | SD | %CV |
| Control
Level 1 | 90 | 6.9 | 0.06 | 0.9 | 0.07 | 1.0 | 0.10 | 1.4 |
| Control
Level 2 | 90 | 9.9 | 0.09 | 0.9 | 0.09 | 0.9 | 0.11 | 1.1 |
| Panel A | 90 | 3.1 | 0.06 | 1.8 | 0.07 | 2.2 | 0.09 | 2.9 |
| Panel B | 90 | 14.2 | 0.11 | 0.8 | 0.12 | 0.8 | 0.15 | 1.1 |
| Panel C | 90 | 23.1 | 0.18 | 0.8 | 0.18 | 0.8 | 0.23 | 1.0 |

a Includes repeatability (within-run), between-run, and between-day variability.

b Includes repeatability (within-run), between-day, and between-instrument variability.

Clinical and Laboratory Standards Institute (CLSI). Evaluation of Quantitative Measurement Procedures; Approved Guideline-Third Edition. CLSI Document EP05-A3. Wayne, PA: CLSI; 2014.

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E. Accuracy

A study was performed to estimate the bias of the Calcium2 assay relative to standard reference material (NIST SRM 956d Level 1 and Level 2). Testing was conducted using 2 concentrations of the standard across 3 lots of the Calcium2 reagent, 2 lots of the Consolidated Chemistry Calibrator, and 1 instrument. The bias ranged from -3.7% to -0.6%.

F. Lower Limits of Measurement - Serum

A study was performed based on guidance from CLSI EP17-A2. * Testing was conducted using 3 lots of the Calcium2 reagent on each of 2 instruments over 3 days. The maximum observed limit of blank (LoB), limit of detection (LoD), and limit of quantitation (LoQ) values are summarized below.

	mg/dL
LoBa	0.1
LoDb	0.2
LoQc	0.4

a The LoB represents the 95th percentile from n ≥ 60 replicates of zero-analyte samples.

b The LoD represents the lowest concentration at which the analyte can be detected with 95% probability based on n ≥ 60 replicates of low-analyte level samples.

6 The LoQ is defined as the lowest concentration at which a maximum allowable precision of 20 %CV was met and was determined from n ≥ 60 replicates of low-analyte level samples.

Clinical and Laboratory Standards Institute (CLSI). Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline-Second Edition. CLSI Document EP17-A2. Wayne, PA: CLSI; 2012.

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G. Lower Limits of Measurement - Urine

A study was performed based on guidance from CLSI EP17-A2. * Testing was conducted using 3 lots of the Calcium2 reagent on each of 2 instruments over 3 days. The maximum observed limit of blank (LoB), limit of detection (LoD), and limit of quantitation (LoQ) values are summarized below.

	mg/dL
LoBa	0.1
LoDb	0.2
LoQc	0.5

a The LoB represents the 95th percentile from n ≥ 60 replicates of zero-analyte samples.

b The LoD represents the lowest concentration at which the analyte can be detected with 95% probability based on n ≥ 60 replicates of low-analyte level samples.

6 The LoQ is defined as the lowest concentration at which a maximum allowable precision of 20 %CV was met and was determined from n ≥ 60 replicates of low-analyte level samples.

H. Linearity - Serum

A study was performed based on guidance from CLSI EP06 2nd ed. *

The assay was demonstrated to be linear from 2.0 to 24.0 mg/dL.

I. Linearity - Urine

A study was performed based on guidance from CLSI EP06 2nd ed.

The assay was demonstrated to be linear from 2.0 to 24.0 mg/dL

Clinical and Laboratory Standards Institute (CLSI). Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline-Second Edition. CLSI Document EP17-A2. Wayne, PA: CLSI: 2012.
Clinical and Laboratory Standards Institute (CLSI). Evaluation of the Linearity of Quantitative Measurement Procedure. 2nd ed. CLSI Document EP06. Wayne, PA: CLSI; 2020.

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J. Potentially Interfering Endogenous and Exogenous Substances - Serum

Potentially Interfering Endogenous Substances

A study was performed based on guidance from EP07 3rd ed. * Each substance was tested at 2 levels of the analyte (approximately 9 mg/dL and 12 mg/dL). No significant interference (interference within ± 5%) was observed at the following

concentrations.

No Significant Interference (Interference within ± 5%)
Potentially Interfering Substance	Interferent Level
Bilirubin (conjugated)	40 mg/dL
Bilirubin (unconjugated)	40 mg/dL
Hemoglobin	1,000 mg/dL
Total protein	15 g/dL
Triglycerides	1500 mg/dL

Clinical and Laboratory Standards Institute (CLSI). Interference Testing in Clinical Chemistry. 3rd ed. CLSI Guideline EP07. Wayne, PA: CLSI; 2018.

18

Potentially Interfering Exogenous Substances

No significant interference (interference within ± 5%) was observed at the following concentrations.

No Significant Interference (Interference within ± 5%)
Potentially Interfering Substance	Interferent Level
Acetaminophen	160 mg/L
Acetylcysteine	150 mg/L
Acetylsalicylic acid	30 mg/L
Ampicillin-Na	80 mg/L
Ascorbic acid	60 mg/L
Ca-dobesilate	46 mg/L
Cefoxitin	6600 mg/L
Cyclosporine	2 mg/L
Doxycycline	20 mg/L
Ibuprofen	220 mg/L
Levodopa	8 mg/L
Magnesium sulfate	50 mg/dL
Methyldopa	25 mg/L
Metronidazole	130 mg/L
Phenylbutazone	330 mg/L
Rifampicin	50 mg/L
Sodium heparin	4 U/mL
Theophylline (1,3-dimethylxanthine)	60 mg/L

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Interference beyond ± 5% (based on 95% Confidence Intervals [CI]) was observed

at the concentrations shown below for the following substance

Interference beyond ± 5% (based on 95% Confidence Interval [CI])
Potentially Interfering
Substance	Interferent Level	Analyte Level	% Interference
(95% CI)
Ca-dobesilate	60 mg/L	9 mg/dL	6%
(5%, 6%)

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K. Potentially Interfering Endogenous and Exogenous Substances - Urine

Potentially Interfering Endogenous Substances

A study was performed based on guidance from EP07 3rd ed. * Each substance was tested at 2 levels of the analyte (approximately 8 mg/dL and 16 mg/dL). No significant interference (interference within ± 5%) was observed at the following concentrations.

No Significant Interference (Interference within ± 5%)
Potentially Interfering Substance	Interferent Level
Ascorbate	100 mg/dL
Glucose	500 mg/dL
Magnesium sulfate	50 mg/dL
Total protein	30 mg/dL
Sample pH	2.5 to 6.0
Urea	5000 mg/dL
Uric acid	92 mg/dL

Clinical and Laboratory Standards Institute (CLSI). Interference Testing in Clinical Chemistry. 3rd ed. CLSI Guideline EP07. Wayne, PA: CLSI; 2018.

21

Potentially Interfering Exogenous Substances

No significant interference (interference within±5%) was observed at the following concentrations.

No Significant Interference (Interference within ± 5%)
Potentially Interfering Substance	Interferent Level
Acetaminophen	16 mg/dL
Acetic acid (8.5N)	5.16 mL/dL
Boric acid	250 mg/dL
Hydrochloric acid (6N)	2.5 mL/dL
Ibuprofen	22 mg/dL
Nitric acid (6N)	5.0 mL/dL

Interference beyond ± 5% (based on 95% Confidence Intervals [CI]) was observed

at the concentrations shown below for the following substance

Interference beyond ± 5% (based on 95% Confidence Interval [CI])
Potentially Interfering
Substance	Interferent Level	Analyte Level	% Interference
(95% CI)
Acetic acid (8.5N)	6.25 mL/dL	8 mg/dL	-7%
(-8%, -6%)

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L. Method Comparison - Serum

A study was performed based on guidance from CLSI EP09c 3rd ed. * using the Passing-Bablok regression method. The study compared the Calcium2 assay to the comparator Calcium assay.

Calcium2 vs Calcium on the ARCHITECT c8000 System
	n	Units	Correlation Coefficient	Intercept	Slope	Concentration Range
Serum	120	mg/dL	1.00	-0.1	1.02	2.3–21.1

M. Method Comparison - Urine

A study was performed based on guidance from CLSI EP09c 3rd ed. * using the Passing-Bablok regression method. The study compared the Calcium2 assay to the comparator Calcium assay.

Calcium2 vs Calcium on the ARCHITECT c8000 System
	n	Units	Correlation Coefficient	Intercept	Slope	Concentration Range
Urine	112	mg/dL	1.00	0.1	0.96	2.1–22.7

Clinical and Laboratory Standards Institute (CLSI). Measurement Procedure Comparison and Bias Estimation Using Patient Samples.3rd ed. CLSI Document EP09c. Wayne, PA: CLSI; 2018.
Clinical and Laboratory Standards Institute (CLSI). Measurement Procedure Comparison and Bias Estimation Using Patient Samples.3rd ed. CLSI Document EP09c. Wayne, PA: CLSI; 2018.

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N. Tube Type Equivalence - Serum

A study was performed to evaluate the suitability of specific blood collection tube types for use with the Calcium2 assay. Samples were collected from 78 donors and evaluated across tube types. The following blood collection tube types were determined to be acceptable for use with the Calcium2 assay:

Serum

Serum tubes •
Serum separator tubes •

Plasma

Lithium heparin tubes •
Lithium heparin separator tubes .
Sodium heparin tubes •

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O. Dilution Verification - Urine

A study was performed based on guidance from CLSI EP34 1st ed. * to evaluate the recovery of the Calcium2 automated and manual dilution, relative to the assigned concentration, on the ARCHITECT c System.

Five samples were prepared to have calcium concentrations within the EMI of the Calcium2 assay by spiking normal human urine with calcium stock (calcium chloride dihydrate solution) to the target concentration values of 26, 41, 56, 71, and 85 mg/dL.

The performance of the automated dilution protocol and manual dilution procedure was considered acceptable if, for samples within the EMI, the dilution recovery was within or equal to 100% ± 10% when comparing auto-diluted or manually diluted samples to target or assigned concentrations and the imprecision was ≤ 5 %CV for the automated dilution protocol and * Clinical and Laboratory Standards Institute (CLSI). Establishing and Verifying an Extended Measuring Interval Through Specimen Dilution and Spiking. 1st ed. CLSI Guideline EP34. Wayne, PA: CLSI; 2018.

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VIII. Summary of Clinical Performance

This section does not apply.

IX. Conclusion Drawn from Nonclinical Laboratory Studies

The results presented in this 510(k) premarket notification demonstrate that the performance of the subject device Calcium2 (LN 04S91), is substantially equivalent to the predicate device, ARCHITECT Calcium (K062855).

The similarities and differences between the subject device and the predicate device are presented in Section VI.

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

Device Description

Mentions image processing

Mentions AI, DNN, or ML

Input Imaging Modality

Anatomical Site

Indicated Patient Age Range

Intended User / Care Setting

Description of the training set, sample size, data source, and annotation protocol

Description of the test set, sample size, data source, and annotation protocol

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Reportable Interval - Serum/Plasma

Reportable Interval – Urine

Within-Laboratory Precision - Serum

1. Within-Laboratory Precision (20-Day)

2. System Reproducibility

Within-Laboratory Precision - Urine

1. Within-Laboratory Precision (20-Day)

2. System Reproducibility

Accuracy

Lower Limits of Measurement - Serum

Lower Limits of Measurement - Urine

Linearity - Serum

Linearity - Urine

Potentially Interfering Endogenous and Exogenous Substances - Serum

Potentially Interfering Endogenous Substances

Potentially Interfering Exogenous Substances

Potentially Interfering Endogenous and Exogenous Substances - Urine

Potentially Interfering Endogenous Substances

Potentially Interfering Exogenous Substances

Method Comparison - Serum

Method Comparison - Urine

Tube Type Equivalence - Serum

Dilution Verification - Urine

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

§ 862.1145 Calcium test system.

Paula V. Caposino -S

Indications for Use

CONTINUE ON A SEPARATE PAGE IF NEEDED.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *

Administrative Documentation - 510(k) Summary (Summary of Safety and Effectiveness)

510(k) Number: K244042

I. Applicant Name

II. Subject Device

III. Predicate Device

IV. Description of Device

A. Principles of the Procedure

B. Reagent

V. Intended Use of the Device

VI. Comparison of Technological Characteristics

Table VI.1

Table VI.2

VII. Summary of Nonclinical Performance

A. Reportable Interval - Serum/Plasma

B. Reportable Interval – Urine

C. Within-Laboratory Precision - Serum

1. Within-Laboratory Precision (20-Day)

2. System Reproducibility

D. Within-Laboratory Precision - Urine

1. Within-Laboratory Precision (20-Day)

2. System Reproducibility

E. Accuracy

F. Lower Limits of Measurement - Serum

G. Lower Limits of Measurement - Urine

H. Linearity - Serum

I. Linearity - Urine

J. Potentially Interfering Endogenous and Exogenous Substances - Serum

Potentially Interfering Endogenous Substances

Potentially Interfering Exogenous Substances

K. Potentially Interfering Endogenous and Exogenous Substances - Urine

Potentially Interfering Endogenous Substances

Potentially Interfering Exogenous Substances

Interference beyond ± 5% (based on 95% Confidence Intervals [CI]) was observed

L. Method Comparison - Serum

M. Method Comparison - Urine

N. Tube Type Equivalence - Serum

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW