K Number

Device Name

PHOENIX ISE REAGENTS FOR BECKMAN CX SYSTEMS

Manufacturer

PHOENIX DIAGNOSTICS, INC.

Date Cleared

2002-06-04

(120 days)

Product Code

JGS CEM CGZ CHL JIX

Regulation Number

862.1665

Intended Use

The pHoenix ISE Reagents for Beckman CX Systems are intended for use as ISE Reagents for the determination of Na , K , C1 and C02 in human serum samples on the Beckman CX Systems. The Electrolyte Buffer is diluted with the Wash Solution and introduced into the serum samples for the quantitative determination of Na+, K+, Cl- and C02. The Electrolyte Reference Reagent is to provide reference points for Na+, K+, C1- and C02. The C02 Acid Reagent is to release C02 from serum samples. The C02 Alkaline Buffer is to provide a constant C02 concentration as reference for the C02 electrode. The Wash Concentrate is intended to be diluted with de-ionized water. The working Wash Solution is used to wash the systems sample probe and to dilute reagents on Beckman CX Systems. The Calibrators are used for the calibration of the CX ISE Modules for the quantitative determination of Na+, K+ Cl+and C02 in serum samples.

Device Description

pHoenix Diagnostics, Inc. is submitting a 510 (k) notification for the following: (1) Electrolyte Buffer, (2) Electrolyte Reference Reagent and (3) C02 Acid Reagent, (4) C02 Alkaline Buffer, (5) Wash Concentrate and (6) ISE Calibrator Level 1,2 and 3. These ISE Reagents are intended for use on the ISE Module of the Beckman CX Systems for the quantitative determination of Na+, K+, C1- and C02 in human serum. The Electrolyte Buffer is intended to provide constant ionic strength for measuring electrolytes in human serum samples. The Electrolyte Buffer is combined with the Wash Solution and introduced into the serum samples for the quantitative determination of Na+, K+, C1- and C02. The Electrolyte Reference Reagent is to provide reference points for Na+, K+, C1- and C02. The C02 Acid Reagent is to release C02 from serum samples, The C02 Alkaline Reagent is to provide a constant C02 concentration as reference for the C02 electrode. The Wash Concentrate is intended to be diluted with de-ionized water. The working Wash Solution is used to wash the systems sample probe and to dilute reagents on Beckman CX Systems. The Calibrators are used for the calibration of the CX ISE Modules.

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Type

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 summary describes reagents and calibrators for an existing laboratory analyzer (Beckman CX Systems) and does not mention any AI or ML components.

Therapeutic

No
The device is described as reagents (Electrolyte Buffer, Reference, C02 Acid, C02 Alkaline, Wash Concentrate, and Calibrators) used for the quantitative determination of Na+, K+, C1-, and C02 in human serum samples. This indicates it is an in vitro diagnostic (IVD) device used for diagnostic purposes, not a therapeutic device which would administer treatment.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the reagents are for "the quantitative determination of Na, K, C1 and C02 in human serum samples," which are measurements used for diagnostic purposes. Additionally, the device is named "pHoenix Diagnostics, Inc." in the "Device Description" section, indicating its diagnostic nature.

SaMD (Software as a Medical Device)

The device description clearly states that the submission is for "ISE Reagents," which are chemical substances used in laboratory testing, not software.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use explicitly states the reagents are for the "determination of Na, K, C1 and C02 in human serum samples". This indicates the device is used to examine specimens derived from the human body.
Device Description: The device description details various reagents (Electrolyte Buffer, Electrolyte Reference Reagent, C02 Acid Reagent, C02 Alkaline Buffer, Wash Concentrate, and ISE Calibrator Levels) that are used "for the quantitative determination of Na+, K+, C1- and C02 in human serum". This further confirms the use of the device to analyze human specimens.
Performance Studies: The performance studies describe the analysis of "serum controls" and "patient serum samples", which are human specimens. The studies evaluate the performance of the reagents in determining the levels of Na, K, Cl, and CO2 in these samples.

All of these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to monitor therapeutic measures.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The pHoenix ISE Reagents for Beckman CX Systems are intended for use as ISE Reagents for the determination of Na , K , C1 and C02 in human serum samples on the Beckman CX Systems.

The Electrolyte Buffer is diluted with the Wash Solution and introduced into the serum samples for the quantitative determination of Na+, K+, Cl- and C02.

The Electrolyte Reference Reagent is to provide reference points for Na+, K+, C1- and C02.

The C02 Acid Reagent is to release C02 from serum samples.

The C02 Alkaline Buffer is to provide a constant C02 concentration as reference for the C02 electrode. The Wash Concentrate is intended to be diluted with de-ionized water. The working Wash Solution is used to wash the systems sample probe and to dilute reagents on Beckman CX Systems.

The Calibrators are used for the calibration of the CX ISE Modules for the quantitative determination of Na+, K+ Cl+and C02 in serum samples.

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

JGS, CEM, CGZ, CHL, JIX

Device Description

The Electrolyte Buffer is intended to provide constant ionic strength for measuring electrolytes in human serum samples. The Electrolyte Buffer is combined with the Wash Solution and introduced into the serum samples for the quantitative determination of Na+, K+, C1- and C02. The Electrolyte Reference Reagent is to provide reference points for Na+, K+, C1- and C02. The C02 Acid Reagent is to release C02 from serum samples, The C02 Alkaline Reagent is to provide a constant C02 concentration as reference for the C02 electrode. The Wash Concentrate is intended to be diluted with de-ionized water. The working Wash Solution is used to wash the systems sample probe and to dilute reagents on Beckman CX Systems. The Calibrators are used for the calibration of the CX ISE Modules.

pHoenix uses a similar composition, description and packaging design as that used by Beckman Coulter in its products.

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)

Method comparison: results obtained on Beckman CX Clinical Chemistry Systems calibrated with pHoenix products compared with results obtained on the same analyzer calibrated with Beckman CX Systems products.
Precision study: pHoenix products were installed on Beckman CX Systems Clinical Chemistry Systems and samples were measured one run per day for a 20 day period.
Precision data was collected from the analysis of 2 levels of serum controls measured 2 runs per day, 2 times per run for 20 days on Beckman CX Systems for Na, K, Cl and C02 installed with pHoenix reagents. The NCCLS Guideline for precision evaluation, EP5-T, was followed.
Correlation data was collected from 50 samples (patient serum samples, control samples and spiked samples) for Na, K, CI and C02 measured on Beckman CX Systems installed with pHoenix reagents (Electrolyte Buffer, Electrolyte Reference Reagent, C02 Alkaline Buffer, C02 Acid Reagent, Wash Cincentrate, and Calibrators) as compared with Beckman Coulter reagents separately. A Linear Regression Analysis was performed using Beckman data as the independent X Variable and pHoenix Diagnostics Data as the Dependent Y Variable in the equation Y = a + bX.

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

Precision:
Level 2:
Na+: Total N=80, Mean=121, STD=1.47, CV%=1.2, Min=120, Max=124. Run to Run N=20, Mean=121, STD=0.67, CV%=0.55, Min=120, Max=123.
K+: Total N=80, Mean=1.93, STD=0.104, CV%=5.42, Min=1.8, Max=2.1. Run to Run N=20, Mean=1.93, STD=0.040, CV%=2.00, Min=1.85, Max=2.0.
Cl-: Total N=80, Mean=70.6, STD=1.42, CV%=2.01, Min=68, Max=73. Run to Run N=20, Mean=70.6, STD=0.87, CV%=1.23, Min=69, Max=72.
C02: Total N=80, Mean=16.25, STD=0.94, CV%=5.8, Min=14.1, Max=17.2. Run to Run N=20, Mean=16.25, STD=0.57, CV%=3.57, Min=14.7, Max=17.2.

Level not specified (assumed Level 1 based on context):
Na+: Total N=80, Mean=164.2, STD=2.58, CV%=1.57, Min=160, Max=169. Run to Run N=20, Mean=164.2, STD=1.07, CV%=0.65, Min=162, Max=166.
K+: Total N=80, Mean=6.50, STD=.062, CV%=0.96, Min=6.4, Max=6.6. Run to Run N=20, Mean=6.50, STD=.028, CV%=0.44, Min=6.4, Max=6.5.
Cl-: Total N=80, Mean=147.5, STD=0.824, CV%=0.56, Min=146, Max=149. Run to Run N=20, Mean=147.5, STD=.473, CV%=.32, Min=147, Max=148.
C02: Total N=80, Mean=34.1, STD=1.87, CV%=5.48, Min=30, Max=39. Run to Run N=20, Mean=34.1, STD=1.28, CV%=3.76, Min=32, Max=37.

Correlation with Beckman Coulter Reagents:
Na+: N=50, Slope=1.027, Intercept=0.60, Correlation Coefficient=0.999, Range=100 - 200.
K+: N=50, Slope=1.04, Intercept=0.348, Correlation Coefficient=0.998, Range=1 - 15.
Cl-: N=50, Slope=0.977, Intercept=7.17, Correlation Coefficient=0.996, Range=50 - 200.
C02: N=50, Slope=0.964, Intercept=1,058, Correlation Coefficient=0.985, Range=5 - 40.

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.

Not Found

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

§ 862.1665 Sodium test system.

(a)
Identification. A sodium test system is a device intended to measure sodium in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.(b)
Classification. Class II.

Summary

JC020364

510 (k) Summary

pHoenix ISE Reagents for Beckman CX Systems

Beckman Instruments was the original manufacturer of the Beckman CX Systems. Recently Beckman Instruments acquired Coulter and these Chemistry Systems continued to be referred to as Beckman CX Systems. Beckman Coulter is the name of the new company.

pHoenix Diagnostics, Inc. is claiming substantial equivalence to predicate devices manufactured by Beckman Coulter, the original manufacturer of these reagents and Beckman CX Systems.

The products encompassed by this 510 (k) submission are Class I and Class II In Vitro Diagnostic Solutions manufactured by pHoenix Diagnostics, Inc., 8 Tech Circle, Natick, MA 01760. These pHoenix ISE Reagents are intended to serve as direct replacements to like named products manufactured by Beckman Coulter.

510 (k) Summary cont.

| pHoenix
Cat.# | Beckman
Cat. # | Description | Models | Class |
|------------------|-------------------|-------------------------------|----------------|-------|
| 47-2095 | 472095 | Electrolyte Buffer | All CX Systems | 1 |
| 45-0214 | 450214 | Electrolyte Reference Reagent | All CX Systems | 2 |
| 44-3320 | 443320 | C02 Alkaline Buffer | All CX Systems | 1 |
| 44-3330 | 443330 | C02 Acid Reagent | All CX Systems | 1 |
| 44-3335 | 443335 | Wash Concentrate | All CX Systems | 1 |
| 46-5908 | 465908 | ISE Calibrator Level 1 | All CX Systems | 2 |
| 46-5909 | 465909 | ISE Calibrator Level 2 | All CX Systems | 2 |
| 46-5910 | 465910 | ISE Calibrator Level 3 | All CX Systems | 2 |

Listed below are pHoenix products and their Beckman Coulter equivalents.

pHoenix uses a similar composition, description and packaging design as that used by Beckman Coulter in its products. pHoenix has shown performance equivalence of its products to Beckman instrument products in the following manner:

. Through a method comparison where results obtained on Beckman CX Clinical Chemistry Systems calibrated with pHoenix products and compared with results obtained on the same analyzer calibrated with Beckman CX Systems products; and
. Through a precision study where pHoenix products were installed on Beckman CX Systems Clinical Chemistry Systems and samples were measured one run per day for a 20 day period.

A summary of the results of these studies follows:

Precision data was collected from the analysis of 2 levels of serum controls measured 2 runs per day, 2 times per run for 20 days on Beckman CX Systems for Na , K , Cl and C02 installed with pHoenix reagents. The NCCLS Guideline for precision evaluation, EP5-T, was followed. Typical Results are as follows: Level 2

Analyte		N	Mean	STD	CV%	Min	Max
Na+	Total	80	121	1.47	1.2	120	124
	Run to Run	20	121	0.67	0.55	120	123
K+	Total	80	1.93	0.104	5.42	1.8	2.1
	Run to Run	20	1.93	0.040	2.00	1.85	2.0
Cl-	Total	80	70.6	1.42	2.01	68	73
	Run to Run	20	70.6	0.87	1.23	69	72
C02	Total	80	16.25	0.94	5.8	14.1	17.2
	Run to Run	20	16.25	0.57	3.57	14.7	17.2

510 (k) Summary cont.

| 1
T
0110
پ
ﺮ
CI
L | 1
t |

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Analyte		N	Mean	STD	CV%	Min	Max
Na+	Total	80	164.2	2.58	1.57	160	169
	Run to Run	20	164.2	1.07	0.65	162	166
K+	Total	80	6.50	.062	0.96	6.4	6.6
	Run to Run	20	6.50	.028	0.44	6.4	6.5
Cl-	Total	80	147.5	0.824	0.56	146	149
	Run to Run	20	147.5	.473	.32	147	148
C02	Total	80	34.1	1.87	5.48	30	39
	Run to Run	20	34.1	1.28	3.76	32	37

Correlation with Beckman Coulter Reagents

Correlation data was collected from 50 samples (patient serum samples, control samples and spiked samples) for Na , K , CI and C02 measured on Beckman CX Systems installed with pHoenix reagents (Electrolyte Buffer, Electrolyte Reference Reagent, C02 Alkaline Buffer, C02 Acid Reagent, Wash Cincentrate, and Calibrators) as compared with Beckman Coulter reagents separately. A Linear Regression Analysis was performed using Beckman data as the independent X Variable and pHoenix Diagnostics Data as the Dependent Y Variable in the equation Y = a + bX. Typical results are as follows:

| Analyte | N | Slope | Intercept | Correlation
Coefficient | Range |
|---------|----|-------|-----------|----------------------------|-----------|
| Na+ | 50 | 1.027 | 0.60 | 0.999 | 100 - 200 |
| K+ | 50 | 1.04 | 0.348 | 0.998 | 1 - 15 |
| Cl- | 50 | 0.977 | 7.17 | 0.996 | 50 - 200 |
| C02 | 50 | 0.964 | 1,058 | 0.985 | 5 - 40 |

I hope you find this information useful and informative.

Ram Nunna, President

2/1/02

Date

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 0 4 2002

Mr. Ram Nunna President pHoenix Diagnostics, Inc. 8 Tech Circle Natick, MA 01760

Re: K020364

Trade/Device Name: pHoenix ISE Reagents for Beckman CX Systems 700/900 series Regulation Number: 21 CFR 862.1665; 21 CFR 862.1600; 21 CFR 862.1170; 21 CFR 862.1120; 21 CFR 862.1150 Regulation Name: Sodium test system; Potassium test system; Chloride test system; Blood gases (Poo2, Po2) and blood pH test system; Calibrator Regulatory Class: Class II Product Code: JGS: CEM; CGZ, CHL, JIX Dated: April 2, 2002 Received: April 8, 2002

Dear Mr. Nunna:

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 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Page 2 -

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" (21CFR 807,97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrb/dsma/dsmamain.html".

Sincerely yours.

Steven Butman

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

INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K0 Z036

Device Name: pHoenix ISE Reagents for Beckman CX Systems 700/900 series

Indications For Use:

Intended Use:

The pHoenix ISE Reagents for Beckman CX Systems are intended for use as ISE Reagents for the determination of Na , K , C1 and C02 in human serum samples on the Beckman CX Systems.

The Electrolyte Buffer is diluted with the Wash Solution and introduced into the serum samples for the quantitative determination of Na+, K+, Cl- and C02.

The Electrolyte Reference Reagent is to provide reference points for Na+, K+, C1- and C02.

The C02 Acid Reagent is to release C02 from serum samples.

The Calibrators are used for the calibration of the CX ISE Modules for the quantitative determination of Na+, K+ Cl+and C02 in serum samples.

(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) OR

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

Dean
Coopy
(Division Sign-Off)
Division of Clinical Laboratory Devices
16. 26364