(61 days)
The pHoenix ISE Reagents for Roche Hitachi 700/900 series are intended for use as ISE Reagents for the determination of Nat, K*, and Cli for the Roche Hitachi 700/900 Series Clinical Chemistry Systems.
The ISE Diluent are intended for use as a diluent for patient samples for the quantitative determination of Nat, K+ and CI in serum by ISE.
The ISE Internal Reference Solutions are intended as a means of compensating for calibration drift in the quantitative determination of Na*, K* and CI in a serum sample on the Roche Hitachi Clinical Chemistry Systems.
The ISE High and Low Standards are intended to provide callbration points for the Na , K and Cl Electrodes on the Roche Hitachi ISE system.
pHoenix ISE reagent for Roche Hitachi Clinical Chemistry 700 and 900 Series Systems: pHoenix Diagnostics, Inc. is submitting a 510 (K) notification for the following: (1) pHoenix ISE Diluent, (2) ISE Internal Reference Solution and (3) ISB Low and High Standards. These ISE Reagents are intended for use on the ISE Module of the Roche Hitachi Clinical Chemistry Systems. The ISE Diluent dilutes all measured patient samples for the quantitative determination of Nat, K* and CI in serum by ISE. The ISE Internal Reference Solutions are intended as a means of compensating for calibration drift in the quantitative determination of Na", K+ and CI' in serum samples on the Roche Hitachi Clinical Chemistry Systems. The ISE High and Low Standards are intended to provide calibration points for the Nat, K+ and Cl Electrodes on the ISE system.
The pHoenix ISE Reagents for Roche/Hitachi Models 700/900 Series were determined to be substantially equivalent to predicate devices manufactured by Roche Diagnostics Corporation based on method comparison and precision studies.
1. A table of acceptance criteria and the reported device performance
The provided text describes performance equivalence in general terms (method comparison and precision study) but does not contain a detailed table of specific acceptance criteria (e.g., specific ranges for bias or precision) or the reported device performance values. It states these reagents are "similar in composition and performance" to Roche Diagnostics equivalents and "have shown performance equivalence."
2. Sample size used for the test set and the data provenance
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective).
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 in the document.
4. Adjudication method for the test set
This information is not provided in the document.
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
A multi-reader multi-case comparative effectiveness study is not applicable as this device is a reagent for in vitro diagnostic testing, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a reagent, not an algorithm. The performance evaluation would be for the reagent's analytical accuracy and precision when used with the specified instruments.
7. The type of ground truth used
The ground truth for evaluating the pHoenix ISE Reagents would likely be established through:
- Reference Method Comparison: Comparing the results obtained using the pHoenix ISE Reagents with those obtained from the predicate device (Roche Diagnostics equivalents) or an established reference method.
- Known Concentration Standards: Using samples with accurately known concentrations of Na+, K+, and Cl- to assess the accuracy of the measurements.
8. The sample size for the training set
This information is not provided, and the concept of a "training set" in the context of analytical reagent performance testing (as opposed to machine learning) is generally not applicable in the same way. Performance studies for reagents typically involve testing across a range of concentrations and conditions to characterize their analytical performance.
9. How the ground truth for the training set was established
As noted above, a "training set" as understood in machine learning is not directly applicable here. For the performance studies, the ground truth would be established by comparing against the predicate device's performance characteristics or recognized analytical standards.
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iagnostics,
NATICK, MA 01760 . TEL: 508-655-8310 . FAX: 508-655-8273
DEC 1 82001
Address:
510 K SUMMARY
K01345/
pHoenix ISE Reagents for Roche/Hitachi Models 700/900 Series.
- Ram Nunna. 1. Submitter:
pHoenix Diagnostics, Inc.
8 Tech Circle
Natick, MA. 01760
508-655-8310 Phone:
Fax: 508-655-8273
Contact Person: Ram Nunna
Date of Summary: 11/9/01
2. Device Name and Associated Information:
Device name: pHoenix ISB Reagents for Roche/Hitachi 700, 900 series.
Trade name: Same as above.
Common name: Same as above.
Classification and Associated Information:
Classification: Calibrator, Multianalyte Mixture.
Device Classification: Class II
Panel: Chemistry 75
Product Code: JIX
- pHoenix ISE Reagents for Roche/Hitachi 700/900 Series Clinical Chemistry Systems
are similar in composition and performance to Roche Diagnostics equivalents.
Attachment: Substantial equivalence comparison.
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agnostics.
· NATICK, MA 01760 · TEL: 508-655-8310 · FAX: 508-655-8273
510 K Summary:
pHoenix ISE reagent for Roche Hitachi Clinical Chemistry 700 and 900 Series Systems: pHoenix Diagnostics, Inc. is submitting a 510 (K) notification for the following: (1) pHoenix ISE Diluent, (2) ISE Internal Reference Solution and (3) ISB Low and High Standards. These ISE Reagents are intended for use on the ISE Module of the Roche Hitachi Clinical Chemistry Systems. The ISE Diluent dilutes all measured patient samples for the quantitative determination of Nat, K* and CI in serum by ISE. The ISE Internal Reference Solutions are intended as a means of compensating for calibration drift in the quantitative determination of Na", K+ and CI' in serum samples on the Roche Hitachi Clinical Chemistry Systems. The ISE High and Low Standards are intended to provide calibration points for the Nat, K+ and Cl Electrodes on the ISE system. pHoenix Diagnostics, Inc. is claiming substantial equivalence to predicate devices manufactured by Roche Diagnostics Corporation. These reagents are intended to serve as a direct replacement to like named products manufactured by Roche Diagnostics. pHoenix uses a similar composition description and packaging design as used by Roche Diagnostics. pHoenix has shown performance equivalence of its products to Roche Diagnostics products in the following manner:
-
- Through method comparison
-
- Through precision study
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iagnostics, II
TECH CIRCLE . NATICK, MA 01760 . TEL: 508-655-8310 . FAX: 508-655-8273
Intended Use:
The pHoenix ISE Reagents for Roche Hitachi 700/900 series are intended for use as ISE Reagents for the determination of Nat, K+ and CI for the Roche Hitachi 700/900 series Clinical Chemistry Systems.
The ISE Diluent are intended for use as a diluent for patient samples for the quantitative determination of Nat, K+ and Cli in serum by ISE.
The ISE Internal Reference Solutions are intended as a means of compensating for calibration drift in the quantitative determination of Na*, K* and CI in a serum sample on the Roche Hitachi Clinical Chemistry Systems.
The ISE High and Low Standards are intended to provide callbration points for the Na , K and Cl Electrodes on the Roche Hitachi ISE system.
| Ram Nunna | |
|---|---|
| Signature: | |
| Date: | 11/9/01 |
| K013451 |
510K Number
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three stylized lines forming the body and wings.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Ram Nunna Contact Person pHoenix Diagnostic Inc. DEC 1 8 2001 8 Tech Circle Natick, MA 01760
K013451 Re: Trade/Device Name: pHoenix ISE Reagents for Roche Hitachi 700/900 series Regulation Number: 21 CFR 862.1665; 21 CFR 862.1600; 21 CFR.1170; 21 CFR 862.1150 Regulation Name: Sodium test system; Potassium test system; Chloride test system; Calibrator Regulatory Class: Class II; Class II, Class II, Class II Product Code: JGS; CEM; CGZ; JIX Dated: October 15, 2001 Received: October 18, 2001
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.
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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 1 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/cdrh/dsmaldsmamain.html".
Sincerely yours,
Steven Sutman
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
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INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K
Device Name: pHoenix ISE Reagents for Roche Hitachi 700/900 series
Indications For Use:
Intended Use:
The pHoenix ISE Reagents for Roche Hitachi 700/900 series are intended for use as ISE Reagents for the determination of Nat, K*, and Cli for the Roche Hitachi 700/900 Series Clinical Chemistry Systems.
The ISE Diluent are intended for use as a diluent for patient samples for the quantitative determination of Nat, K+ and CI in serum by ISE.
The ISE Internal Reference Solutions are intended as a means of compensating for The ISE Internal Kelefence Solutions are mination of NaT, K* and CI in serum samples on the Roche Hitachi Clinical Chemistry Systems.
The ISE High and Low Standards are intended to provide calibration points for the Nat, The IST Electrodes on the Roche Hitachi ISE system.
Thomas (Santo) In Jean Correa
Division Sign. Dep
Division of Clinical Laboratory Devices K 013451 510(k) Number .
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
1 Prescription Use (Pex 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
§ 862.1170 Chloride test system.
(a)
Identification. A chloride test system is a device intended to measure the level of chloride in plasma, serum, sweat, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.(b)
Classification. Class II.