K Number

Device Name

HICHEM CALCIUM REAGENT KIT

Manufacturer

HICHEM DIAGNOSTICS

Date Cleared

1998-07-29

(69 days)

Product Code

CJY

Regulation Number

862.1145

Intended Use

HiChem Calcium Reagent is intended for the quantitative determination of total calcium in serum, plasma and 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).

Device Description

The HiChem Calcium Reagent determines calcium by its reaction with arsenazo III to form a blue complex. The resulting increase in absorbance at 650 nm is proportional to the calcium concentration in the sample. The HiChern Calcium Reagent is an adaptation of the arsenazo III calcium method, first reported by Michaylova and Illikova and is intended to be used either as a manual procedure or on clinical analyzers which can automate the required manipulations.

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Center

Panel

Date Received

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Device Name

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Class Advise Committee

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Third Party Reviewed

Expedited Review

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies detail a chemical reaction and spectrophotometric measurement, with no mention of AI or ML.

Therapeutic

No.
Explanation: This device is an in vitro diagnostic reagent used to quantitatively determine total calcium levels in patient samples, which aids in diagnosis and treatment monitoring rather than directly treating a condition.

Diagnostic

Yes

Explanation: The device is intended for the quantitative determination of total calcium in serum, plasma, and urine, and calcium measurements are used in the diagnosis and treatment of various diseases, which aligns with the definition of a diagnostic device.

SaMD (Software as a Medical Device)

The device is a chemical reagent intended for laboratory use, not a software-only medical device. It describes a chemical reaction and its application in a manual procedure or on clinical analyzers.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use explicitly states "quantitative determination of total calcium in serum, plasma and urine." This is a diagnostic measurement performed on biological samples in vitro (outside the body).
Purpose: The calcium measurements are used "in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany." This directly links the test results to medical diagnosis and treatment decisions.
Device Description: It describes a reagent that reacts with a sample to produce a measurable result (absorbance) that is proportional to the analyte concentration. This is a typical characteristic of an IVD reagent.
Intended User/Care Setting: It is intended for use in a "professional setting or by trained personnel," which is consistent with the use of IVD devices in clinical laboratories or healthcare settings.
Performance Studies: The document details performance studies (linearity, precision, comparison to a predicate device) which are required for IVD devices to demonstrate their analytical performance.
Predicate Device: The mention of a "Predicate Device(s)" with a K number (K981794; Beckman® Systems Calcium Reagent) is a strong indicator that this device is being submitted for regulatory clearance as an IVD, as predicate devices are used for comparison in the 510(k) submission process for IVDs.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

HiChem Calcium Reagent is intended for the quantitative determination of total calcium in serum, plasma and urine for the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
This reagent is intended to be used in a professional setting or by trained personnel and is not intended for home use.

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

CJY

Device Description

The HiChern Calcium Reagent is an adaptation of the arsenazo III calcium method, first reported by Michaylova and Illikova and is intended to be used either as a manual procedure or on clinical analyzers which can automate the required manipulations.

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

professional setting or by trained personnel

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)

The effectiveness of the manual procedure is shown by the recovery of linearity standards, the precision of control recoveries, the comparison of serum, plasma and urine recoveries to the Beckman® Calcium Reagent and the validation of the chemical additives and sensitivity claims.

The recovery of total calcium using HiChem Calcium Reagent as a manual procedure is linear between 0.1 to 16 mg/dL as shown by the recovery of linearity standards which span 0 to 18 mg/dL.
Precision, demonstrated by replicate assay of urine pools and commercially available control sera.
Calcium recoveries of 92 mixed serum and plasma specimens are compared between the HiChem manual procedure and the Beckman® SYNCHRON® Calcium Reagent.
The use of sodium heparin, lithium heparin and lithium iodoacetate are shown to be acceptable chemical additives by comparison of spiked serum pools.
The sensitivity claim of 0.2 mg/dL is documented through the repettive assay of a diluted serum control.

The effectiveness of the HiChem secondary reagent application for the Beckman® SYNCHRON CX® Systems is shown by the recovery of linearity standards, the precision of control recovery of serum controls over both the calibration stability and on-board stability claims, the validation of the chemical additives and sensitivity claims, and the comparison of patient specimen recoveries to the Beckman® SYNCHRON® Systems Calcium Reagent.

The recovery of total calcium using the HiChem CA Reagent on the SYNCHRON CX® Systems is linear from at least 2.0 mg/dL to 15.0 mg/dL as shown by the recovery of six linearity standards which span the claimed linear range.
Precision, demonstrated by replicate assay of urine pools and commercially available control sera.
Calcium recoveries of 153 mixed serum and plasma specimens are compared between the HiChem and Beckman® CA Reagents on the SYNCHRON CX® Systems.
The use of sodium heparin, lithium heparin and lithium iodoacetate are shown to be acceptable chemical additives by comparison of spiked serum pools.
The sensitivity claim of 2.0 mg/dL is documented through the repetitive assay of a diluted serum control.
The 14 day onboard calibration stability and the 30 day on board reagent stability claims are documented through the assay of serum controls and urine pools over the claimed periods.

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

Manual Procedure:

Regression statistics for linearity: sy.x = 0.14 mg/dL., (HiChem Recoveries) = - 0.1 mg/dL + 0.980 x (Standard Conc.), r^2 = 1.000, df = 23
Precision:
- Serum control 1 (n=30): mean=6.69 mg/dL, within-run SD=0.21 mg/dL, total SD=0.24 mg/dL
- Serum control 2 (n=30): mean=12.68 mg/dL, within-run SD=0.29 mg/dL, total SD=0.30 mg/dL
- Urine Pool 1 (n=30): mean=2.41 mg/dL, within-run SD=0.11 mg/dL, total SD=0.11 mg/dL
- Urine Pool 2 (n=30): mean=11.10 mg/dL, within-run SD=0.13 mg/dL, total SD=0.16 mg/dL
Serum/Plasma Comparisons (n=92): (HiChem Results) = -0.3 mg/dL + 1.020 × (BMD® Results), r² = 0.887, s(y.x) = 0.21 mg/dL
Urine Comparisons: (HiChem Results) = 0.2 mg/dL + 1.022 × (BMD® Results), r² = 0.998, s(y.x) = 0.15 mg/dL
Bias from additives: less than 0.1 mg/dL
Observed sensitivity limit: 0.15 mg/dL

SYNCHRON CX® Systems Application:

Regression statistics for linearity: (HiChem Recoveries) = 0.0 mg/dL + 0.967 × (Standard Conc.), r2 = 1.000. sy.x = 0.08 mg/dL, df = 29
Precision:
- Serum control 1 (n=60): mean=6.89 mg/dL, within-run SD=0.056 mg/dL, total SD=0.064 mg/dL
- Serum control 2 (n=60): mean=10.03 mg/dL, within-run SD=0.085 mg/dL, total SD=0.089 mg/dL
- Serum control 3 (n=60): mean=13.21 mg/dL, within-run SD=0.088 mg/dL, total SD=0.090 mg/dL
- Urine Pool 1 (n=60): mean=3.24 mg/dL, within-run SD=0.048 mg/dL, total SD=0.059 mg/dL
- Urine Pool 2 (n=60): mean=11.64 mg/dL, within-run SD=0.075 mg/dL, total SD=0.095 mg/dL
Serum/Plasma Comparisons (n=153): (HiChem Results) = -0.3 mg/dL + 1.005 x (Beckman® Results), r² = 0.924, s(y.x) = 0.20 mg/dL
Urine Comparisons: (HiChem Results) = 0.1 mg/dL + 1.031 x (Beckman® Results), r² = 0.996, s(y.x) = 0.16 mg/dL
Observed biases from additives: less than 0.2 mg/dL.
Observed sensitivity limit: less than 0.15 mg/dL
Imprecision of calcium recoveries over claimed intervals for onboard calibration stability and reagent stability: less than the greater of 0.26 mg/dL or 2.6%

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.

Beckman® Systems Calcium Reagent, product no. 442755

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

JUL 20 1998

Image /page/0/Picture/1 description: The image shows the logo for HiChem Diagnostics. The logo features the text "HiChem" in a bold, stylized font, with the word "Diagnostics" underneath in a smaller font. Above and to the left of the text is a solid black circle. To the right of the circle are the words "Smart Solutions".

9817-94

SUMMARY OF 510(K) SAFETY AND EFFECTIVENESS INFORMATION

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 HiChern Calcium Reagent is substantially equivalent to the Beckman® Systems Calcium Reagent, product no. 442755, manufactured by Beckman® Instruments, Brea, CA. Both reagents support the same intended use and produce substantially equivalent results with the same clinical purpose. In addition, they are methodology which determines total calcium through the colorimetric measurement the calcium - arsenazo III complex.

The recovery of total calcium using HiChem Calcium Reagent as a manual procedure is linear between 0.1 to 16 mg/dL as shown by the recovery of linearity standards which span 0 to 18 mg/dL. Regression statistics are shown below.

sy.x = 0.14 mg/dL., (HiChem Recoveries) = - 0.1 mg/dL + 0.980 x (Standard Conc.), r2 = 1.000, df = 23

Precision, demonstrated by replicate assay of urine pools and commercially available control sera, is shown below.

Specimen	n	mean	within-run SD	total SD
Serum control 1	30	6.69 mg/dL	0.21 mg/dL	0.24 mg/dL
Serum control 2	30	12.68 mg/dL	0.29 mg/dL	0.30 mg/dL
Urine Pool 1	30	2.41 mg/dL	0.11 mg/dL	0.11 mg/dL
Urine Pool 2	30	11.10 mg/dL	0.13 mg/dL	0.16 mg/dL

Calcium recoveries of 92 mixed serum and plasma specimens are compared between the HiChem manual procedure and the Beckman® SYNCHRON® Calcium Reagent, used on the SYNCHRON CX® Systems. Least squares regression statistics are shown below.

Serum/ Plasma Comparisons:
(HiChem Results) = -0.3 mg/dL + 1.020 × (BMD® Results)	r² = 0.887	s(y.x) = 0.21 mg/dL
Urine Comparisons:
(HiChem Results) = 0.2 mg/dL + 1.022 × (BMD® Results)	r² = 0.998	s(y.x) = 0.15 mg/dL

The use of sodium heparin, lithium heparin and lithium iodoacetate are shown to be acceptable chemical additives by comparison of spiked serum pools. In all cases, the biases produced by the additive were less than 0.1 mg/dL.

The sensitivity claim of 0.2 mg/dL is documented through the repettive assay of a diluted serum control. The observed sensitivity limit, calculated as three standard deviations of a 30 recision study, is 0.15 mg/dl. and is below the claimed limit of 0.2 mg/dL.

510(k) Notification, HiChem Calcium Reagent Kit, p 61

20 May, 1998

2024 Native Student Orientation Schedule: August 18, 2024

The recovery of total calcium using the HiChem CA Reagent on the SYNCHRON CX® Systems is linear from at least 2.0 mg/dL to 15.0 mg/dL as shown by the recovery of six linearity standards which span the claimed linear range. Regression statistics are shown below.

(HiChem Recoveries) = 0.0 mg/dL + 0.967 × (Standard Conc.), r2 = 1.000. sy.x = 0.08 mg/dL, df = 29

Precision, demonstrated by replicate assay of urine pools and commercially available control sera, is shown below.

Specimen	n	mean	within-run SD	total SD
Serum control 1	60	6.89 mg/dL	0.056 mg/dL	0.064 mg/dL
Serum control 2	60	10.03 mg/dL	0.085 mg/dL	0.089 mg/dL
Serum control 3	60	13.21 mg/dL	0.088 mg/dL	0.090 mg/dL
Urine Pool 1	60	3.24 mg/dL	0.048 mg/dL	0.059 mg/dL
Urine Pool 2	60	11.64 mg/dL	0.075 mg/dL	0.095 mg/dL

Calcium recoveries of 153 mixed serum and plasma specimens are compared between the HiChem and Beckman® CA Reagents on the SYNCHRON CX® Systems. Least squares regression statistics are shown below.

Serum/ Plasma Comparisons:

(HiChem Results) = -0.3 mg/dL + 1.005 x (Beckman® Results) $r^2$ = 0.924	s(y.x) = 0.20 mg/dL
Urine Comparisons:
(HiChem Results) = 0.1 mg/dL + 1.031 x (Beckman® Results) $r^2$ = 0.996	s(y.x) = 0.16 mg/dL

The use of sodium heparin, lithium heparin and lithium iodoacetate are shown to be acceptable chemical additives by comparison of spiked serum pools. In all cases, the observed biases were less than 0.2 mg/d..

The sensitivity claim of 2.0 mg/dL is documented through the repetitive assay of a diluted serum control. The observed sensitivity limit, calculated as three standard deviations of a 30 replicate within run precision study, is less than 0.15 mg/dL and is well below the claimed limit of 2.0 mg/dL.

The 14 day onboard calibration stability and the 30 day on board reagent stability claims are documented through the assay of serum controls and urine pools over the claimed periods. In all cases, estimates of imprecision of calcium recoveries over the claimed intervals are less than the greater of 0.26 mg/dL or 2.6%, which is the manufacturer's total precision claim for the SYNCHRON® Analyzer.

The HiChem Calcium Reagent is shown to be safe and effective and substantially equivalent to the Beckman® SYNCHRON® Systems Calcium Reagent, product no. 442755, manufactured by Beckman® Instruments, Brea, CA.

Wynne Stocking

Manager of Regulatory Affairs HiChem Diagnostics

510(k) Notification, HiChem Calcium Reagent Kit, p 62

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 2 9 1998

Wynn Stocking . Manager, Regulatory Affairs HiChem Diagnostics 231 North Puente Street Brea, California 92821

K981794 Re : HiChem Calcium Reagent Regulatory Class: II Product Code: CJY Dated: May 20, 1998 Received: May 21, 1998

Dear Mr. Stocking:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

This letter will allow you to begin marketing your device as described in your 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Autman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices ----------Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Page 1 of 1

K981794 510(k) Number (if known):

Device Name:

HiChem Calcium Reagent Kit

Indications For Use:

HiChem Calcium Reagent is intended for the quantitative determination of total calcium in serum, Hichent Calcioin Reagent is mended for the qualifical disease, a variety of bone plasma and unne for the the tradinons and telany (intermittent muscular contractions or spasms).

This reagent is intended to be used in a professional setting or by trained personnel and Is not intended for home use.

Respectfully.

Wynn Stordins

Regulatory Affairs Manager HiChem Diagnostics

2 Juno, 1998

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use __
(Optional Format 1-2-96)