(62 days)
Not Found
No
The document describes a chemical reagent for quantitative determination of inorganic phosphorus and does not mention any AI/ML components or functionalities. The performance studies focus on standard analytical chemistry metrics like method comparison and imprecision.
No
This device is a diagnostic reagent used for the quantitative determination of inorganic phosphorus in human samples, which aids in the diagnosis and monitoring of disorders, rather than providing therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Measurements of phosphorus (inorganic) are used in the diagnosis and incasuromento of in disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance." This indicates that the device assists in diagnosing medical conditions.
No
The device description clearly states it is a "reagent" and a "reagent kit," which are chemical substances used in laboratory tests, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The document explicitly states the device is "for use in the quantitative determination of inorganic phosphorus in human serum, plasma, or urine." This is a classic description of an in vitro diagnostic test, as it involves analyzing biological samples outside of the body to provide information for diagnosis and management of conditions.
- Device Description: It describes a "reagent" used in conjunction with "SYNCHRON® Systems," which are laboratory analyzers. This further confirms its use in a laboratory setting for diagnostic testing.
- Performance Studies: The document includes performance data like method comparison and imprecision, which are standard evaluations for IVD devices to demonstrate their accuracy and reliability.
- Predicate Device: The mention of a "Predicate Device" with a K number (K883181) is a strong indicator that this device is being submitted for regulatory clearance as an IVD, as predicate devices are used to demonstrate substantial equivalence to existing legally marketed IVDs.
Therefore, based on the provided information, the PHS reagent is clearly an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
PHS reagent, in conjunction with SYNCHRON® Systems and SYNCHRON Multi Calibrator, is intended for use in the quantitative determination of inorganic phosphorus concentration in human serum, plasma, or urine. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of renal disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.
Product codes
CFO
Device Description
The SYNCHRON Systems PHS reagent is designed for optimal performance on the CX (CX4CE/4/4PRO, CX5CE/52/5PRO, CX7/7RTS/7A/7PRO, SYNCHRON CX9ALX/9PRO) and LX (LX20/PRO/LXi 725) Systems. The reagent kit contains two 300-test cartridges that are packaged separately from the associated calibrator.
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
The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Equivalence is demonstrated through method comparison, linearity, and imprecision experiments.
SYNCHRON CX Systems PHS Method Comparison Study Results
Candidate Method: SYNCHRON Systems PHS Reagent. Sample Type: Serum. Slope: 0.997. Intercept: -0.04. R: 0.998. n: 114. Predicate Method: Beckman Coulter SYNCHRON PO4 Assay on CX Systems.
Sample Type: Urine. Slope: 0.976. Intercept: 0.25. R: 0.996. n: 81. Predicate Method: Beckman Coulter SYNCHRON PO4 Assay on CX Systems.
Within-Run Imprecision
Sample: Serum 1. Mean (mg/dL): 2.0. S.D. (mg/dL): 0.05. %C.V.: 2.4. N: 80.
Sample: Serum 2. Mean (mg/dL): 6.6. S.D. (mg/dL): 0.09. %C.V.: 1.4. N: 80.
Sample: Urine 1. Mean (mg/dL): 41.1. S.D. (mg/dL): 0.43. %C.V.: 1.0. N: 80.
Sample: Urine 2. Mean (mg/dL): 78.3. S.D. (mg/dL): 0.91. %C.V.: 1.2. N: 80.
Total Imprecision
Sample: Serum 1. Mean (mg/dL): 2.0. S.D. (mg/dL): 0.05. %C.V.: 2.7. N: 80.
Sample: Serum 2. Mean (mg/dL): 6.6. S.D. (mg/dL): 0.10. %C.V.: 1.5. N: 80.
Sample: Urine 1. Mean (mg/dL): 41.1. S.D. (mg/dL): 0.61. %C.V.: 1.5. N: 80.
Sample: Urine 2. Mean (mg/dL): 78.3. S.D. (mg/dL): 1.26. %C.V.: 1.6. N: 80.
SYNCHRON LX20 System PHS Estimated Imprecision.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1580 Phosphorus (inorganic) test system.
(a)
Identification. A phosphorus (inorganic) test system is a device intended to measure inorganic phosphorus in serum, plasma, and urine. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.(b)
Classification. Class I (general 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
AUG 1 8 2004
510(k) Summary SYNCHRON® Systems Phosphorus (PHS) Reagent
Submitted By: 1.0
Mary Beth Tang Staff Regulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd., W-104 Brea, California 92822-8000 Telephone: (714) 961-3777 FAX: (714) 961-4123
2.0 Date Submitted:
June 15, 2004
Device Name(s): 3.0
Proprietary Names 3.1 SYNCHRON® Systems Phosphorus (PHS) Reagent
3.2 Classification Name Phosphorus (inorganic) test system (21 CFR § 862.1580)
4.0 Predicate Device:
| Candidate(s) | Predicate | Manufacturer | Docket
Number |
|----------------------------------|----------------------------------|---------------------------|------------------|
| SYNCHRON® Systems
PHS Reagent | SYNCHRON® Systems
PO4 Reagent | Beckman Coulter,
Inc.* | K883181 |
*Beckman Coulter, Inc., Brea, CA
5.0 Description:
The SYNCHRON Systems PHS reagent is designed for optimal performance on the CX (CX4CE/4/4PRO, CX5CE/52/5PRO, CX7/7RTS/7A/7PRO, SYNCHRON CX9ALX/9PRO) and LX (LX20/PRO/LXi 725) Systems. The reagent kit contains two 300-test cartridges that are packaged separately from the associated calibrator.
6.0 Intended Use:
PHS reagent, in conjunction with SYNCHRON Systems and SYNCHRON Multi Calibrator, is intended for use in the quantitative determination of inorganic phosphorus concentration in human serum, plasma, or urine.
1
7.0 Comparison to Predicate(s):
The following table shows similarities and differences between the predicates identified in Section 4.0 of this summary.
| Similarities | ||
|---|---|---|
| PHS Reagent | Intended Use | Same as Beckman Coulter |
| SYNCHRON CX Systems | ||
| Methodology | PO4 Reagent | |
| Reactive Ingredients | ||
| Sample Types | ||
| Detection Wavelength | ||
| Reaction Volumes (reagent, sample) | ||
| Shelf Life | ||
| Differences | ||
| Reaction Type (endpoint) | PHS: Sample-blanked | |
| PO4: Reagent-blanked | ||
| TCA precipitation method (for serum | ||
| proteins) | PHS: Compatible | |
| PO4: Incompatible | ||
| Instrument Platforms: | PHS: CX CE/Δ/PRO Systems, | |
| LX20/PRO/LXi Systems | ||
| PO4: CX Systems only |
8.0 Summary of Performance Data:
The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Equivalence is demonstrated through method comparison, linearity, and imprecision experiments.
SYNCHRON CX Systems PHS Method Comparison Study Results
| Candidate Method | Sample
Type | Slope | Intercept | R | n | Predicate Method |
|------------------------------------|----------------|-------|-----------|-------|-----|--------------------------------------------------------|
| SYNCHRON
Systems PHS
Reagent | Serum | 0.997 | -0.04 | 0.998 | 114 | Beckman Coulter
SYNCHRON PO4 Assay
on CX Systems |
| | Urine | 0.976 | 0.25 | 0.996 | 81 | |
| Sample | Mean (mg/dL) | S.D. (mg/dL) | %C.V. | N |
|---|---|---|---|---|
| Within-Run Imprecision | ||||
| Serum 1 | 2.0 | 0.05 | 2.4 | 80 |
| Serum 2 | 6.6 | 0.09 | 1.4 | 80 |
| Urine 1 | 41.1 | 0.43 | 1.0 | 80 |
| Urine 2 | 78.3 | 0.91 | 1.2 | 80 |
| Total Imprecision | ||||
| Serum 1 | 2.0 | 0.05 | 2.7 | 80 |
| Serum 2 | 6.6 | 0.10 | 1.5 | 80 |
| Urine 1 | 41.1 | 0.61 | 1.5 | 80 |
| Urine 2 | 78.3 | 1.26 | 1.6 | 80 |
SYNCHRON LX20 System PHS Estimated Imprecision
This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with a serpent entwined around it. The symbol is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement. The logo is black and white.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 1 8 2004
Ms. Mary Beth Tang Staff Regulatory Affairs Specialist Beckman Coulter, Inc 200 South Kraemer Blvd. P.O. Box 8000 Brea, CA 92821
K041643 Re:
Korrollo
Trade/Device Name: SYNCHRON® Systems Phosphorus (PHS) Reagent Regulation Number: 21 CFR 862.1580 Regulation Name: Phosphorus (inorganic) test system Regulatory Class: Class I Product Code: CEO Dated: June 15, 2004 Received: June 17, 2004
Dear Ms. Tang:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed four been wing 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 encreated of the enactment date of the Medical Device Amendments, or to conninered processified 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). and Cosmetic roll (110.) that 80 novice, subject to the general controls provisions of the Act. The r ou may, dicrorolo, mains of the Act include requirements for annual registration, listing of genoral controls provincitive, 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 it may be subject it bach adde of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Eederal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease oc advised that i Dri 3 localite over device complies with other requirements of the Act that I DA has made a actuations administered by other Federal agencies. You must or any it coord statutes and equirements, including, but not limited to: registration and listing (21 comply with and the right (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
3
Page 2
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and w yourse FDA finding of substantial equivalence of your device to a legally prematication "Thesults in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, if you destre spoorne miss and advertising of your device, please contact the Office of or Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I ou may outling 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,
Sean M. Cooper, MS, DVM.
Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
K041643
Device Name:
SYNCHRON® Systems Phosphorus (PHS) Reagent
Indications for Use:
PHS reagent, in conjunction with SYNCHRON® Systems and SYNCHRON PTIS reagent, in ochjanoued for use in the quantitative determination of inorganic phosphorus in human serum, plasma, or urine.
Measurements of phosphorus (inorganic) are used in the diagnosis and incasuromonto of in disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.
x Prescription Use (Part 21 CFR 801 Subpart D) Over-the-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol C. Benson
Division Sign Off
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K041643
Page 1 of 1