(61 days)
No Predicate Devices were found. The section "Predicate Device(s)" explicitly states "Not Found".
Not Found
No
The document describes standard laboratory reagents and calibration materials for an existing clinical chemistry system, with no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is described as reagents, diluents, and standards for a clinical chemistry system used to determine ion levels, which are diagnostic tools, not therapeutic devices.
No
Explanation: The device is described as reagents, diluent, and standards used for the quantitative determination of Nat, K*, and Cl in serum samples on clinical chemistry systems. These components are used for the measurement of analytes, which is a step in diagnostic processes, but the device itself does not interpret or diagnose; it provides data for diagnostic purposes.
No
The device description clearly states that the submission is for "ISE Reagents" which are physical substances (diluent, reference solutions, standards) used in a clinical chemistry system, not software.
Based on the provided text, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the reagents are for the "determination of Na+, K+, and Cl-" in patient samples (serum). This is a diagnostic purpose, as these measurements are used to assess a patient's health status.
- Device Description: The description further clarifies that these are "ISE Reagents" used on "Clinical Chemistry Systems" for the "quantitative determination" of these analytes in serum. This aligns with the definition of an in vitro diagnostic product, which is used to examine specimens taken from the human body to provide information for diagnostic purposes.
- Performance Studies: The mention of "method comparison" and "precision study" are typical performance evaluations for IVD devices to demonstrate their accuracy and reliability.
Therefore, the device described is intended for use in a laboratory setting to perform diagnostic tests on patient samples, which is the core function of an IVD.
N/A
Intended Use / Indications for 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 calibration drift in the quantitative determination 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, K and Cl Electrodes on the Roche Hitachi ISE system.
Product codes
JIX, JGS, CEM, CGZ
Device Description
pHoenix ISE Reagents for Roche/Hitachi 700/900 Series Clinical Chemistry Systems are similar in composition and performance to Roche Diagnostics equivalents.
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.
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
pHoenix has shown performance equivalence of its products to Roche Diagnostics products in the following manner:
-
- Through method comparison
-
- Through precision study
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
1
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
2
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
3
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.
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 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
5
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)