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K Number
K023268
Device Name
PHOENIX ISE STANDARD A,B AND C FOR ROCHE/AVL SYSTEMS
Manufacturer
PHOENIX DIAGNOSTICS, INC.
Date Cleared
2002-11-15

(46 days)

Product Code
JIX
Regulation Number
862.1150
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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.
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.
More Information

Not Found

AVL 983, AVL 984, AVL 985

No
The document describes in vitro diagnostic reagents (standards) used for calibrating instruments that measure electrolytes in serum. There is no mention of any computational algorithms, image processing, or AI/ML terms. The performance studies focus on method comparison and precision, which are standard for IVD reagents.

No
The device is an in vitro diagnostic reagent used for calibration and quantitative determination of certain ions in human serum samples, not for direct therapy.

No
The device is described as "ISE Reagents" and "Standards" used for the "calibration of the Roche AVL Instruments for the quantitative determination of Na+, K+, Cl+, Ca+ and Li+". It is an "In Vitro Diagnostic Solution" and does not perform a direct diagnostic function itself; rather, it enables diagnostic devices to function correctly.

No

The device description clearly states that the product is "In Vitro Diagnostic Solutions" and "reagents," which are physical substances, not software. The submission is for replacement standards used for calibration, which are also physical components.

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

Here's why:

  • Intended Use: The document explicitly states the intended use is for the "determination of Na', K', Cli, Ca and Li* in human serum samples" and for the "calibration of the Roche AVL Instruments for the quantitative determination of Nat, K* Cl*, Ca* and Li+ in serum samples." This clearly indicates the device is used to analyze human biological samples in vitro (outside the body) to provide information about a person's health.
  • Device Description: The description identifies the products as "Class II (75 JIX) In Vitro Diagnostic Solutions." The classification code (75 JIX) is also associated with IVD devices.
  • Performance Studies: The document describes performance studies like "Method Comparison" and "Precision Study" using "patient serum samples" and "serum controls," which are typical evaluations for IVD devices.

The entire context of the document, including the intended use, device description, and performance studies, points to this device being an In Vitro Diagnostic.

N/A

Intended Use / Indications for 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.

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

JIX

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.

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)

Precision Study:

  • Study Type: Precision study following NCCLS Guideline for precision evaluation, EP5-T.
  • Sample Size: 2 levels of serum controls measured 2 runs per day, 2 times per run for 20 days (total N=80 for each level/analyte combination).
  • Key Results:
    • AVL 983:
      • Na: Level 1 (Mean 124, STD 1.52, CV% 1.2), Level 3 (Mean 164, STD 2.6, CV% 1.6)
      • K: Level 1 (Mean 1.93, STD 0.11, CV% 5.5), Level 3 (Mean 6.5, STD 0.06, CV% 0.96)
      • Cl: Level 1 (Mean 85.6, STD 1.4, CV% 1.7), Level 3 (Mean 148, STD 0.82, CV% 0.56)
    • AVL 984:
      • Na: Level 1 (Mean 124, STD 1.48, CV% 1.2), Level 3 (Mean 165, STD 1.75, CV% 1.06)
      • K: Level 1 (Mean 1.91, STD 0.105, CV% 5.5), Level 3 (Mean 6.7, STD 0.101, CV% 1.52)
      • Ca: Level 1 (Mean 2.36, STD 0.112, CV% 4.76), Level 3 (Mean 0.84, STD 0.014, CV% 1.69)
    • AVL 985 (implied from table format):
      • Na: Level 1 (Mean 123, STD 1.33, CV% 1.1), Level 3 (Mean 165, STD 1.73, CV% 1.05)
      • K: Level 1 (Mean 1.84, STD 0.08, CV% 4.43), Level 3 (Mean 6.6, STD 0.12, CV% 1.85)
      • Li: Level 1 (Mean 1.75, STD 0.087, CV% 5), Level 3 (Mean 2.56, STD 0.1, CV% 3.71)

Correlation Study with Roche AVL Reagents:

  • Study Type: Method comparison/Correlation study using Linear Regression Analysis (Y = a + bX).
  • Sample Size: 50 samples (patient serum samples, control samples and spiked samples) for each analyte/model on Roche AVL Systems.
  • Key Results:
    • Na+:
      • 983: Slope 1.03, Intercept -1.36, Correlation Coefficient 0.992
      • 984: Slope 1.03, Intercept -0.71, Correlation Coefficient 0.996
      • 985: Slope 1.03, Intercept 0.98, Correlation Coefficient 0.994
    • K+:
      • 983: Slope 1.005, Intercept 0.32, Correlation Coefficient 0.996
      • 984: Slope 1.001, Intercept 0.29, Correlation Coefficient 0.998
      • 985: Slope 0.98, Intercept 0.402, Correlation Coefficient 0.997
    • Cl-:
      • 983: Slope 0.98, Intercept 6.18, Correlation Coefficient 0.997
    • Ca+:
      • 984: Slope 1.02, Intercept 0.02, Correlation Coefficient 0.997
    • Li+:
      • 985: Slope 0.989, Intercept 0.03, Correlation Coefficient 0.998

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

  • Precision: Standard Deviation (STD), Coefficient of Variation (CV%)
  • Correlation: Slope, Intercept, Correlation Coefficient

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 (The summary states "pHoenix Diagnostics, Inc. is claiming substantial equivalence to predicate devices manufactured by Roche/AVL Diagnostics." but does not provide K/DEN numbers.)

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

§ 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.

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 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.

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

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

AnalyteLevelNMeanSTDCV%MinMax
Na1801241.521.2121127
Na3801642.61.6162166
K1801.930.115.51.72.2
K3806.50.060.966.46.6
Cl18085.61.41.78289
Cl3801480.820.56146149

AVL 984

AnalyteLevelNMeanSTDCV%MinMax
Na1801241.481.2121127
Na3801651.751.06162170
K1801.910.1055.51.72.2
K3806.70.1011.526.46.8
Ca1802.360.1124.762.22.6
Ca3800.840.0141.690.810.87

2

510 (k) Summary cont.

| △
1

1VLતે 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
AnalyteLevelNMeanSTDCV%MinMax
Na1801231.331.1121126
Na3801651.731.05162170
K1801.840.084.431.72
K3806.60.121.856.46.8
Li1801.750.08751.61.9
Li3802.560.13.712.42.8

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 | 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 | .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 .