The pHoenix ISE Standard for Roche AVL Instruments are intended for use as ISE Reagents for the determination of Na', K', Cli, Ca and Li* in human serum samples on the Roche AVL Systems.

The standards are used for the calibration of the Roche AVL Instruments for the quantitative determination of Nat, K* Cl*, Ca* and Li+ in serum samples.

Device Description

pHoenix Diagnostics, Inc. is submitting a 510 (k) notification for Standard A. B. and C for the Roche AVL Systems for the quantitative determination of Na+, K+, Cl-, Ca+ and Li+ in human serum. These Standards are used for the calibration of the Roche AVL Systems.

The products encompassed by this 510 (k) submission are Class II (75 JIX) In Vitro Diagnostic Solutions manufactured by pHoenix Diagnostics, Inc., 8 Tech Circle, Natick, MA 01760. These pHoenix ISE Standards are intended to serve as direct replacements to like named products manufactured by Roche Diagnostics.

pHoenix Diagnostics uses a similar composition and design as that used by Roche Diagnostics in its products.

AI/ML Overview

The provided text describes the performance of "pHoenix ISE Standards for Roche AVL Systems," which are intended for the quantitative determination of Na+, K+, Cl-, Ca+, and Li+ in human serum. These standards are used for the calibration of Roche AVL Systems.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria (e.g., "CV% must be less than X%"). Instead, it presents precision data and correlation data to demonstrate performance equivalence to the predicate device. The implicit acceptance criterion is that the performance of the pHoenix standards should be comparable to or within acceptable limits for a clinical assay, as demonstrated by the precision and correlation studies.

Precision Study Results (Typical - Specific acceptance criteria are not explicitly stated within each table):

Analyte	Level	N	Mean	STD	CV%	Min	Max
AVL 983
Na	1	80	124	1.52	1.2	121	127
Na	3	80	164	2.6	1.6	162	166
K	1	80	1.93	0.11	5.5	1.7	2.2
K	3	80	6.5	0.06	0.96	6.4	6.6
Cl	1	80	85.6	1.4	1.7	82	89
Cl	3	80	148	0.82	0.56	146	149
AVL 984
Na	1	80	124	1.48	1.2	121	127
Na	3	80	165	1.75	1.06	162	170
K	1	80	1.91	0.105	5.5	1.7	2.2
K	3	80	6.7	0.101	1.52	6.4	6.8
Ca	1	80	2.36	0.112	4.76	2.2	2.6
Ca	3	80	0.84	0.014	1.69	0.81	0.87
AVL 985
Na	1	80	123	1.33	1.1	121	126
Na	3	80	165	1.73	1.05	162	170
K	1	80	1.84	0.08	4.43	1.7	2
K	3	80	6.6	0.12	1.85	6.4	6.8
Li	1	80	1.75	0.087	5	1.6	1.9
Li	3	80	2.56	0.1	3.71	2.4	2.8

Correlation Study Results (Implicit Acceptance Criteria: Correlation Coefficient close to 1, Slope close to 1, Intercept close to 0):

Analyte	AVL Model	N	Slope	Intercept	Correlation Coefficient	Range
Na+	983	50	1.03	-1.36	0.992	75 - 178
Na+	984	50	1.03	-0.71	0.996	74 - 177
Na+	985	50	1.03	0.98	0.994	75 - 177
K+	983	50	1.005	0.32	0.996	2.9 - 6.7
K+	984	50	1.001	0.29	0.998	2.8 - 6.7
K+	985	50	0.98	0.402	0.997	3.1 - 6.8
Cl-	983	50	0.98	6.18	0.997	52 - 151
Ca+	984	50	1.02	0.02	0.997	0.7 - 2.2
Li+	985	50	0.989	0.03	0.998	0.3 - 2.4

2. Sample sizes used for the test set and the data provenance

Precision Study: For each analyte and level, N=80 measurements were performed across 20 days (2 runs per day, 2 times per run). These were conducted on Roche AVL Systems using "2 levels of serum controls." The provenance is not explicitly stated as country of origin, but the study was performed in the context of demonstrating equivalence for US market clearance, implying compliance with US regulatory expectations. The samples used were "serum controls." The study design (20 days, 2 runs/day, 2 measurements/run) is typical for prospective precision studies in clinical laboratories.
Correlation Study: N=50 samples were used for each analyte/AVL model combination. These samples included "patient serum samples, control samples and spiked samples." The provenance is not explicitly stated. This appears to be a prospective comparison, where samples were measured with both the predicate and test devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided. For this type of in vitro diagnostic device (calibrators), ground truth is typically established by reference methods or gravimetric/volumetric preparation for control materials, rather than expert interpretation of patient data. The "ground truth" in the correlation study would be the results obtained from the predicate Roche Diagnostics reagents.

4. Adjudication method for the test set

This is not applicable as this is a quantitative analytical device, not an interpretative device where adjudication of human readers is performed. The "adjudication" is essentially the comparison of numerical results between the predicate and test device using statistical methods (linear regression).

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. The device is an in vitro diagnostic calibrator, not an AI-assisted diagnostic tool that involves human readers.

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

This is applicable in the sense that the device's performance (precision and correlation) was evaluated independently of human interpretation of results, as it is a calibrator. The "algorithm" here refers to the Roche AVL System's measurement process, which the calibrators enable. The performance presented is the standalone performance of the calibrators enabling the instrument.

7. The type of ground truth used

Precision study: The "ground truth" for evaluating precision is the measured mean and variation around that mean for the control materials. The known target values of the control materials serve as a reference.
Correlation study: The "ground truth" for the purpose of demonstrating substantial equivalence is the measurements obtained using the Roche Diagnostics reagents (the predicate device). The pHoenix Diagnostics reagents are compared against these predicate results.

8. The sample size for the training set

This device is not an AI/machine learning algorithm, so there is no "training set" in the conventional sense. The development of the pHoenix ISE Standards would involve formulation and testing to ensure they meet concentration specifications, but this is a manufacturing/chemistry process, not an AI training process.

9. How the ground truth for the training set was established

Not applicable, as there is no "training set" for an AI algorithm. The performance of the calibrators themselves is established through rigorous chemical and analytical validation processes to ensure their stated concentrations are accurate and stable.

Summary

{0}------------------------------------------------

K023268

NOV 1 5 2002

510 (k) Summary

pHoenix ISE Standards for Roche AVL Systems

AVL was the original manufacturer of the AVL Systems. Recently Roche Diagnostics acquired AVL and these Chemistry Systems are now referred to as Roche AVL Systems.

pHoenix Diagnostics, Inc. is claiming substantial equivalence to predicate devices manufactured by Roche/AVL Diagnostics.

pHoenixCat.#	RocheDiagnostics Cat. #	Description andUtilities	Analytes and Concentrations
			Na	K	Cl	Ca	Li	CO2	pH
4-001	BP0936	Standard A forAVL 982,983,985	150	5	115	0.9	0.3	/	/
4-009	BP0937	Standard B forAVL 985	100	1.8	72	1.5	0.3	/	/
4-010	BP0938	Standard C forAVL 985	150	5	115	0.9	1.4	/	/
4-005	BP0442	Standard B forAVL 982, 983	50	1.8	59.8	4	/	/	/
4-006	BP1232	Standard A forAVL 984, 987, 988	150	5	/	1.25	/	/	7.38
4-007	BP1218	Standard B forAVL 984, 987, 988	100	1.8	/	2.5	/	/	6.84
4-011	BP1203	Standard A forAVL 986	150	5	125.3	/	/	25	/
4-012	BP1201	Standard B forAVL 986	80	1.8	70.9	/	/	10	/

Listed below are pHoenix products, their Roche Diagnostics equivalents and usages on the Roche AVL instruments:

{1}------------------------------------------------

510 (k) Summary cont.

pHoenix Diagnostics uses a similar composition and design as that used by Roche Diagnostics in its products. pHoenix has shown performance equivalence of its products to Roche Diagnostics products in the following manner:

. Through a method comparison where results obtained on Roche AVL Systems calibrated with pHoenix products and compared with results obtained on the same analyzer calibrated with Roche Diagnostics products; and
Through a precision study where pHoenix products were installed on Roche AVL . systems and samples were measured over 20 runs.

A summary of the results of these studies is as 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 Roche AVL Systems for different electrolytes installed with pHoenix reagents. The NCCLS Guideline for precision evaluation, EP5-T, was followed. Typical Results are as follows:

AVL 983

Analyte	Level	N	Mean	STD	CV%	Min	Max
Na	1	80	124	1.52	1.2	121	127
Na	3	80	164	2.6	1.6	162	166
K	1	80	1.93	0.11	5.5	1.7	2.2
K	3	80	6.5	0.06	0.96	6.4	6.6
Cl	1	80	85.6	1.4	1.7	82	89
Cl	3	80	148	0.82	0.56	146	149

AVL 984

Analyte	Level	N	Mean	STD	CV%	Min	Max
Na	1	80	124	1.48	1.2	121	127
Na	3	80	165	1.75	1.06	162	170
K	1	80	1.91	0.105	5.5	1.7	2.2
K	3	80	6.7	0.101	1.52	6.4	6.8
Ca	1	80	2.36	0.112	4.76	2.2	2.6
Ca	3	80	0.84	0.014	1.69	0.81	0.87

{2}------------------------------------------------

510 (k) Summary cont.

△11	VL	તે જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં પ્રાથમિક શાળા, આંગણવાડી તેમ જ દૂધની ડેરી જે

Analyte	Level	N	Mean	STD	CV%	Min	Max
Na	1	80	123	1.33	1.1	121	126
Na	3	80	165	1.73	1.05	162	170
K	1	80	1.84	0.08	4.43	1.7	2
K	3	80	6.6	0.12	1.85	6.4	6.8
Li	1	80	1.75	0.087	5	1.6	1.9
Li	3	80	2.56	0.1	3.71	2.4	2.8

Correlation with Roche AVL Reagents

Correlation data was collected from 50 samples (patient serum samples, control samples and spiked samples) for Na*, K*, Cl*, Ca* and Li* measured on Roche AVL Systems installed with pHoenix reagents as compared with Roche Diagnostics reagents separately. A Linear Regression Analysis was performed using Roche 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:

	AVL Model	N	Slope	Intercept	CorrelationCoefficient	Range
Na+	983	50	1.03	-1.36	0.992	75 - 178
Na+	984	50	1.03	-0.71	0.996	74 - 177
Na+	985	50	1.03	0.98	0.994	75 - 177
K+	983	50	1.005	0.32	0.996	2.9 - 6.7
K+	984	50	1.001	0.29	0.998	2.8 - 6.7
K+	985	50	0.98	0.402	0.997	3.1 - 6.8
Cl-	983	50	0.98	6.18	0.997	52 - 151
Ca+	984	50	1.02	0.02	0.997	0.7 - 2.2
Li+	985	50	.989	0.03	0.998	0.3 - 2.4

I hope you find this information useful and informative.

Ram Nunna, President

8/20/02

Date

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows a logo for the Department of Health & Human Services USA. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a human figure, with three wavy lines forming the body and head.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

NOV 5 2002

Re: K023268

Trade/Device Name: pHoenix ISE Standards for Roche AVL 982, 983, 984, 985, 986, 987, 988, 9110/9140, 9120/9130, 9180/9181

Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: August 20, 2002 Received: September 30, 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. Iisting 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.

{4}------------------------------------------------

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/cdrl/dsma/dsmamain.html".

Sincerely yours,

Steven Putman

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

{5}------------------------------------------------

INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K_0 232 68

Device Name: pHoenix ISE Standards for Roche AVL 982, 983, 984, 985, 986, 987 988, 9110/9140, 9120/9130, 9180/9181

Indications For Use:

Intended Use:

The pHoenix ISE Standard for Roche AVL Instruments are intended for use as ISE Reagents for the determination of Na', K', Cli, Ca and Li* in human serum samples on the Roche AVL Systems.

The standards are used for the calibration of the Roche AVL Instruments for the quantitative determination of Nat, K* Cl*, Ca* and Li+ 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 OR Over-The-Counter Use (Per 21 CFR 801.109) (Optional Format 1-2-96)

Seun Oguns

ision Sion-Off ivision of Clinical Laboratory Devices 510(k) Number .

Regulation Number and Section

§ 862.1150 Calibrator.

(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.