(64 days)
The pHoenix Electrolyte Calibrator Set is intended for use as calibrators to calibrate Na ", K ", CI and TCO2 for the Dade/Behring Dimension® Chemistry System with MultiPLY™ Integrated Multisensor module installed.
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. The Calibration Set consists of an A, B and Clevel and is intended for use in calibrating Nat, K., C." and TCO2 analytes on the Dade/Behring Dimension Chemistry Systems. Dade/Behring Chemistry Systems, Inc. is the original equipment manufacturer (OEM) of the system,
Here's an analysis of the provided 510(k) summary, extracting the requested information:
Acceptance Criteria and Device Performance Study (K012509)
The pHoenix Electrolyte Calibration Set is intended for use in calibrating Na+, K+, Cl-, and TCO2 analytes on the Dade/Behring Dimension® Chemistry Systems with the MultiPLY™ Integrated Multisensor module installed. The device seeks substantial equivalence to Alko Diagnostic Corporation products.
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state numerical acceptance criteria (e.g., specific ranges of bias or correlation coefficients). Instead, it focuses on demonstrating "performance equivalence" to a predicate device. Therefore, the "reported device performance" is framed as achieving equivalence.
| Analyte | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Na+ | Demonstrated performance equivalence to Alko products | Achieved performance equivalence in method comparison and precision studies |
| K+ | Demonstrated performance equivalence to Alko products | Achieved performance equivalence in method comparison and precision studies |
| Cl- | Demonstrated performance equivalence to Alko products | Achieved performance equivalence in method comparison and precision studies |
| TCO2 | Demonstrated performance equivalence to Alko products | Achieved performance equivalence in method comparison and precision studies |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Description: Not explicitly defined with a distinct "test set" sample size. The studies described are performance equivalence studies rather than a validation against a labeled ground truth.
- Method Comparison:
- Sample Size: Not specified. The study involved comparing results from the Dade/Behring Dimension Chemistry System calibrated with pHoenix products versus the same analyzer calibrated with Alko products. The number of samples (patient samples or control samples) used for this comparison is not provided.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
- Precision Study:
- Sample Size: "samples were measured over 20 runs." The number of distinct samples used across these 20 runs is not specified, nor is the number of replicates per sample per run.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for this device is based on the performance of the predicate device (Alko Diagnostic Corporation products). This is a calibration set, and its performance is evaluated based on its ability to enable accurate measurement of analytes by the instrument. There is no mention of human experts establishing a ground truth in the traditional sense of diagnostic interpretation.
4. Adjudication Method for the Test Set
Not applicable. This is a calibration set for an in vitro diagnostic device, not a diagnostic imaging or interpretive aid that would typically involve human adjudication of results. The "adjudication" is implicitly the instrument's determination of analyte concentrations after calibration, which is then compared to a predicate's performance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This type of study is typically performed for diagnostic imaging devices or assistive technologies where human readers interpret results. This submission concerns a calibration set for an automated chemistry analyzer, where human interpretation is not the primary function being assessed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, effectively. The device being evaluated is a calibration set, which is an integral part of the automated chemistry system's measurement process. The studies described (method comparison, precision) assess the performance of the calibration set in the context of the automated system, without direct human intervention in the measurement of analyt the primary focus. The performance assessed is of the calibration set itself, enabling the instrument to produce accurate results.
7. The Type of Ground Truth Used
The "ground truth" for the equivalence demonstration is the performance of the predicate device, specifically the Alko Diagnostic Corporation calibration products when used with the Dade/Behring Dimension Chemistry Systems. The pHoenix calibration set aims to achieve similar performance. There is no mention of a primary, independent "gold standard" ground truth like pathology or outcomes data.
8. The Sample Size for the Training Set
Not applicable. This device is a calibration set, not a machine learning algorithm that requires a training set. Its function is to provide known concentrations to the instrument for calibration.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set in the context of this device.
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OCT - 9 2001
510 (k) Summary
pHoenix Electrolyte Calibration Set for the Dade/Behring Dimension® Chemistry Systems with MultiPLYTM Integrated Multisensor module installed
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. The Calibration Set consists of an A, B and Clevel and is intended for use in calibrating Nat, K., C." and TCO2 analytes on the Dade/Behring Dimension Chemistry Systems. Dade/Behring Chemistry Systems, Inc. is the original equipment manufacturer (OEM) of the system,
The pHoenix products stated are currently cleared under docker K902675. Information herein will support pHoenix's position to extend the intended use of these products to the Dade Behring Dimension "Chemistry Systems with MultiPLY™ Integrated Multisensor module installed. The MultiPLY™ Integrated Multisensor module measures Nat, K, and Cli by using Integrated Multiple Technology means. The TCO2 analyte is measured by the system's Ion Selective Blectrode. The pHoenix Calibrator Reagents are intended to serve as direct replacements to like named products manufactured by Alko Diagnostic Corporation. PHoenix Product Calibrator A is equivalent to Alko Product A202-0. . pHoenix Product Calibrator B is equivalent to Alko Product A 103-0. . pHoenix Product Calibrator C is equivalent to Alko Product A200-0.
pHoenix uses a similar composition, description and packaging design as that used by Alko Diagnostic Corporation in its products. pHoenix has shown performance equivalence of its products to Alko Diagnostic Corporation products in the following manner:
- Through a method comparison where results obtained on a Dade/Behring Dimension Chemistry Systems . with MultiPLYM Integrated Multisensor module installed, calibrated with pHoenix products and compared with results obtained on the same analyzer calibrated with Alko products; and
- . Through a precision study where pHoenix products were installed on a Dade/Behring Dimension on Chemistry Systems with MultiPLY™ Integrated Multisensor module installed and samples were measured over 20 runs.
Image /page/0/Picture/9 description: The image shows the text "pHoenix Diagnostics, Inc.". The text is in a bold, sans-serif font. The word "pHoenix" is larger than the rest of the text. The text is black and the background is white.
RAM NUNNA
PRESIDENT
8 TECH CIRCLE NATICK MA 01760
TEL: 508-866-8310
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird in flight, composed of three curved lines. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird image.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT - 9 2001
Mr. Ram Nunna President pHoenix Diagnostic Inc. 8 Tech Circle Natick, MA 01760
Re: K012509
K012507
Trade/Device Name: pHoenix Electrolyte Calibration Set for the Dade/Behring/Behring Dimension® Chemistry System
Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: July 30, 2001 Received: August 6, 2001
Dear Mr. Nunna:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enorosule) to regard the Medical Device Amendments, or to conninered pror to rias 2017 3) in accordance with the provisions of the Federal Food, Drug, de vices that have been require approval of a premarket approval application (PMA). and Cosmette Tree, market the device, subject to the general controls provisions of the Act. The I ou may, dierelore, mains of the Act include requirements for annual registration, listing of general controls provisions 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 If your device is classined (500 a00 vy als. Existing major regulations affecting your device can may be subject to back as acceral 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 I lease be actived that I Drivination that your device complies with other requirements of the Act that I Dri has made a active and regulations administered by other Federal agencies. You must or any I could statutes and regisments, including, but not limited to: registration and listing (21 comply with an the rice orequirements (1); good manufacturing practice requirements as set CI It Fat 6077; adoming (Dr CFR Part 820); and if applicable, the electronic rordline and quality by stations (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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/cdrh/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
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INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K 012509.
Device Name: pHoenix Electrolyte Calibration Set for the Dade/Behring/Behring Dimension_ Chemistry System
Indications For Use:
Intended Use:
The pHoenix Electrolyte Calibrator Set is intended for use as calibrators to calibrate Na ", K ", CI and TCO2 for the Dade/Behring Dimension® Chemistry System with MultiPLY™ Integrated Multisensor module installed.
(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)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. H012509
§ 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.