Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a chemical reagent kit for quantitative in vitro determination of Calcium. There is no mention of AI or ML in the intended use, device description, or performance studies. The studies focus on analytical performance metrics typical for chemical assays.

Therapeutic

No.
The device is an in vitro diagnostic (IVD) device used for the quantitative determination of calcium in biological samples to aid in the diagnosis and treatment of conditions, not for direct therapeutic intervention.

Diagnostic

Yes

The "Intended Use / Indications for Use" section states, "Such measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases and chronic renal failure." This explicitly indicates its use in diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "ready to use reagent solution," which is a chemical substance, not software. The performance studies also focus on analytical performance of a chemical assay.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is intended for "quantitative in vitro determination in serum, plasma and urine." The term "in vitro" is a key indicator of an IVD.
Purpose: The intended use also mentions that these measurements are "used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases and chronic renal failure." This indicates the device is used for medical purposes related to diagnosis and treatment, which is a core function of IVDs.
Device Description: The description mentions a "ready to use reagent solution," which is a common component of IVD kits used for chemical analysis of biological samples.
Performance Studies: The document details various performance studies (Precision, Linearity, Analytical Specificity, Method comparison) which are standard requirements for demonstrating the analytical performance of an IVD.
Predicate Device: The mention of a "Predicate Device(s)" with a K number (K083386) indicates that this device is being compared to a previously cleared IVD, a common process in regulatory submissions for IVDs.

All of these factors strongly point to the Randox Calcium (Ca) device being an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Randox Calcium (Ca) device is intended for the quantitative in vitro determination in serum, plasma and urine. This product is suitable for use on the RX series analyzer, RX daytona plus. Such measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases and chronic renal failure.

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

CJY

Device Description

The Randox Calcium (Ca) kit consists of a ready to use reagent solution.
CATALOGUE NUMBER: CA8309
R1. Arsenazo III Reagent 4 x 20 ml
REAGENT COMPOSITION
R1. Arsenazo III Reagent: Sodium Acetate 54.2 mmol/l, pH 5.9; Arsenazo approx.. 230µmol/l; Non-Reactive Stabilisers

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

Prescription Use (Part 21 CFR 801 Subpart D)

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)

Analytical performance:
- Precision/Reproducibility: Evaluated consistent with C.L.S.I documents EP05-A3. Performed on one RX daytona plus system using two levels of controls, calibration material and human serum samples for Calcium. Urine precision studies performed for Calcium using two levels of urine controls, calibration material and human urine samples for Calcium. Testing conducted twice per day for 20 non consecutive days, two replicates per run.
- Linearity/assay reportable range: Carried out in accordance with C.L.S.I. standard EP6-A. Performed at 11 levels.
  - Serum Linearity Summary for Calcium:
    - Lot 1: Linear Regression y = 1.01x - 0.04, Correlation Coefficient r = 1.00, Reportable Range 1.0 - 16 mg/dL
    - Lot 2: Linear Regression y = 1.02x + 0.04, Correlation Coefficient r = 1.00, Reportable Range 1.0 - 16 mg/dL
    - The reportable range of the assay for serum and plasma samples is 1.0 - 16 mg/dL.
  - Urine Linearity Summary for Calcium:
    - Lot 1: Linear Regression y = 0.99x + 0.20, Correlation Coefficient r = 1.00, Reportable Range 1.0 - 32 mg/dL
    - Lot 2: Linear Regression y = 0.98x + 0.28, Correlation Coefficient r = 1.00, Reportable Range 1.0 - 32 mg/dL
    - The reportable range of the assay for urine samples is 1.0 - 32 mg/dL.
- Analytical Specificity: Effects of potential interferents determined by calculating the mean value of the spiked interferent with the corresponding control solution. Spiked sample results compared to control samples prepared without the potential interferents. Sponsor's Acceptance Criteria: a deviation of

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 logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 23, 2018

Randox Laboratories Ltd. Pauline Armstrong Senior QA/Regulatory Affairs Manager 55 Diamond Road Crumlin, Co. Antrim, BT29 4QY GB

Re: K182042

Trade/Device Name: Randox Calcium (Ca) Regulation Number: 21 CFR 862.1145 Regulation Name: Calcium test system Regulatory Class: Class II Product Code: CJY Dated: July 27, 2018 Received: July 30, 2018

Dear Pauline Armstrong:

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. 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 located 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.

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

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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Kellie B. Kelm -S

for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known)

K182042

Device Name

RANDOX CALCIUM (Ca)

Indications for Use (Describe)

The Randox Calcium (Ca) device is intended for the quantitative in vitro determination in serum, plasma and urine. This product is suitable for use on the RX series analyzer, RX daytona plus. Such measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases and chronic renal failure.

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

Z Prescription Use (Part 21 CFR 801 Subpart D)

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

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RANDOX 510(k) Summary: RANDOX CALCIUM (Ca)

1. SAFETY AND EFFECTIVENESS AS REQUIRED BY 21 CFR 807.92 STATEMENT

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

SUBMITTER NAME AND ADDRESS 2.

Name: Dr Pauline Armstrong

Address: Randox Laboratories Limited 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom.

Telephone: +44 (0) 28 9442 2413 Fax: +44 (0) 28 9445 2912 E-mail: Pauline.Armstrong@randox.com

Date of Summary Preparation: 16 October 2018

3. 510k NUMBER. DEVICE PROPRIETARY NAME. COMMON NAME. PURPOSE FOR SUBMISSION, REGULATORY CLASSIFCATION, PANEL, PRODUCT CODE AND 21 CFR NUMBER

510k No: K182042

RANDOX CALCIUM (Ca) Device Proprietary Name:

Common Name: RANDOX CALCIUM (Ca)

Purpose for Submission: New Device

| Product

Code	Regulation Name	Classification	Regulation Section
CJY	Calcium test
system	II	21 CFR 862.1145	Clinical Chemistry
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Image /page/4/Picture/0 description: The image shows the Randox logo followed by the text "510(k) Summary: RANDOX CALCIUM (Ca)". The Randox logo is in green with a red circle in the middle of the "O". The text is in black and appears to be part of a document or presentation.

4. PREDICATE DEVICE PROPRIETARY NAMES AND 510 (k) NUMBERS

Predicate Device Proprietary Name:

ADVIA Chemistry Calcium_2 (CA_2) Method, 510(k) Number: K083386

5. INTENDED USE

The Randox Calcium (Ca) device is intended for the quantitative in vitro determination of calcium concentration in serum, plasma and urine. This product is suitable for use on the RX series analyzer RX daytona plus. Such measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases and chronic renal failure.

6. DEVICE DESCRIPTION

The Randox Calcium (Ca) kit consists of a ready to use reagent solution.

CATALOGUE NUMBER: CA8309

R1. Arsenazo III Reagent

4 x 20 ml

REAGENT COMPOSITION

Contents	Initial Concentration of Solutions
RI. Arsenazo III Reagent
Sodium Acetate	54.2 mmol/l, pH 5.9
Arsenazo	approx.. 230µmol/l
Non-Reactive Stabilisers

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7. PREDICATE DEVICE COMPARISON TABLE

Table 1 Comparison of the Randox Calcium (Ca), with the Advia Chemistry Calcium_2 (CA_2) Method

| CHARACTERISTICS | ADVIA
Method | Chemistry Calcium_2 (CA_2) | Randox Calcium (Ca) |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | 510(k) K083386 | 510(k) K182042 |
| INTENDED USE | A calcium test system intended for the
quantitative in vitro determination of calcium
concentration in serum, plasma and urine on
the ADVIA Chemistry systems, | | A calcium test system intended for the
quantitative in vitro determination of
calcium concentration in serum, plasma
and urine on the RX series analyser RX
daytona plus. |
| ASSAY PROTOCOL | Arsenazo III | | Arsenazo III |
| STORAGE
(UNOPENED) | Reagents stable to expiry when stored at
+15 to +25 ° C | | Reagents stable to expiry when stored at
+15 to +25 ° C |
| SAMPLE TYPE | Human serum, plasma & urine | | Same |
| REAGENT
COMPOSITION | Sodium acetate (pH 5.9)
54.4 mmol/l | | Sodium acetate (pH 5.9)
54.4 mmol/l |
| | Arsenazo III
188μmol/l | | Arsenazo
approx. 230μmol/l |
| | Non-reactive stabilizers | | Non-reactive stabilizers |
| FORMAT | Liquid ready to use | | Liquid ready to use |
| MEASURING
RANGE | Serum/Plasma
1.0 mg/dL - 16 mg/dL | | Serum/Plasma
1.0 mg/dL - 16 mg/dL |
| | Urine
1.0 mg/dL - 32 mg/dL | | Urine
1.0 mg/dL - 32 mg/dL |
| DEVICE
CLASSIFICATION | | Calcium test system | |

The Randox Calcium (Ca) device has the same intended use as the predicate device. Any differences in the technical characteristics between the candidate and predicate device do not affect the safety or effectiveness. Therefore, the Randox Calcium (Ca) device demonstrates substantial equivalence to the predicate device.

8. TEST PRINCIPLE

Arsenazo III specifically binds to Calcium ions to form a coloured complex at 660nm.

pH 5.9 Ca2+ + Arsenazo III --------------------------------------------------------------------------------------------------------------------------------------------------------Ca-Arsenazo III Complex (purple)

The amount of calcium present in the sample is directly proportional to the intensity of the coloured complex formed.

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RANDOX 510(k) Summary: RANDOX CALCIUM (Ca)

9. PERFORMANCE CHARACTERISTICS

Analytical performance:

a. Precision/Reproducibility:

Precision was evaluated consistent with C.L.S.I documents EP05-A3 'Evaluation of Precision of Quantitative Measurement Procedures: Approved Guideline -Third Edition.

Precision studies were performed on one RX daytona plus system using two levels of controls, calibration material and human serum samples for Calcium.

Urine precision studies were performed for Calcium using two levels of urine controls, calibration material and human urine samples for Calcium.

Testing was conducted twice per day for 20 non consecutive days. Two replicates per run were performed for each sample.

The results are summarized in the tables below:

Calcium Serum Precision Summary

Lot 1
System: RX daytona plus			Within Run		Total
Method	Product	Mean	SD	CV %	SD	CV %
		(mg/dL)
Ca	Serum Level 1	3.89	0.12	3.1	0.16	4.1
Ca	Serum Level 2	6.61	0.16	2.4	0.24	3.6
Ca	Serum Level 3	10.78	0.28	2.6	0.40	3.7
Ca	Serum Level 4	13.95	0.32	2.3	0.52	3.7

Lot 2

System: RX daytona plus			Within Run		Total
Method	Product	Mean
(mg/dL)	SD	CV
%	SD	CV
%
Ca	Serum Level 1	3.85	0.08	2.1	0.16	4.2
Ca	Serum Level 2	6.65	0.16	2.4	0.28	4.2
Ca	Serum Level 3	10.70	0.24	2.2	0.44	4.1
Ca	Serum Level 4	13.83	0.32	2.3	0.56	4.0

Calcium Urine Precision Summary

Lot 1

System: RX daytona plus			Within Run		Total
Method	Product	Mean	SD	CV	SD	CV
		(mg/dL)		%		%
Ca	Urine Level 1	6.05	0.16	2.6	0.28	4.6
Ca	Urine Level 2	7.94	0.16	2.0	0.32	4.0
Ca	Urine Level 3	15.07	0.40	2.7	0.60	4.0
Ca	Urine Level 4	25.97	0.56	2.2	1.00	3.9

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510(k) Summary: RANDOX CALCIUM (Ca)

Lot 2

System: RX daytona plus			Within Run		Total
Method	Product	Mean	SD	CV	SD	CV
		(mg/dL)		%		%
Ca	Urine Level 1	6.05	0.16	2.6	0.24	4.0
Ca	Urine Level 2	7.90	0.20	2.5	0.32	4.1
Ca	Urine Level 3	15.11	0.36	2.4	0.60	4.0
Ca	Urine Level 4	26.05	0.52	2.0	0.96	3.7

b. Linearity/assay reportable range:

Linearity studies have been carried out in accordance with C.L.S.I. standard EP6-A. Linearity studies were performed at 11 levels to determine the analytical range of an assay - that is the range where the reported result is a linear function to the analyte concentration (or where deviation from linearity is less than 5%).

The linearity samples were prepared at 11 levels including levels below and above the claimed measuring range.

The results are summarized as follows:

Serum Linearity Summary for Calcium

Lot	Linear Regression	Correlation Coefficient r	Reportable Range
Lot 1	$y = 1.01x - 0.04$	1.00	1.0 - 16 mg/dL
Lot 2	$y = 1.02x + 0.04$	1.00	1.0 - 16 mg/dL

The reportable range of the assay for serum and plasma samples is 1.0 - 16 mg/dL.

Urine Linearity Summary for Calcium

Lot	Linear Regression	Correlation Coefficient r	Reportable Range
Lot 1	y = 0.99x + 0.20	1.00	1.0 - 32 mg/dL
Lot 2	y = 0.98x + 0.28	1.00	1.0 - 32 mg/dL

The reportable range of the assay for urine samples is 1.0 - 32 mg/dL.

c. Analytical Specificity:

The effects of potential interferents were determined by calculating the mean value of the spiked interferent with the corresponding control solution. The spiked sample results were compared to control samples prepared without the potential interferents. Sponsor's Acceptance Criteria: a deviation of