(243 days)
Not Found
No
The device description details a standard turbidimetric assay and calculation based on a non-linear calibration curve, with no mention of AI or ML terms or methodologies.
No.
The device is a diagnostic reagent for measuring albumin in urine to aid in the diagnosis of kidney dysfunction, not for treating a disease or condition.
Yes
The 'Intended Use / Indications for Use' section explicitly states that the device "aids in the diagnosis of kidney dysfunction."
No
The device is a reagent (chemical substance) used in conjunction with a hardware system (SYNCHRON CX® System) to perform a quantitative determination. It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of albumin (MA) concentration in human urine." This involves testing a sample taken from the human body (urine) outside of the body (in vitro).
- Device Description: The description details a "turbidimetric method" using "specific antibody" to measure albumin concentration in urine. This is a laboratory-based test performed on a biological sample.
- Performance Studies: The document includes performance studies like method comparison and precision studies, which are typical for IVD devices to demonstrate their analytical performance.
- Predicate Device: The mention of a "Predicate Method: IMMAGE Microalbumin (MA) Reagent" and a "Predicate Device(s) (K number(s) and name(s); separate multiples with ";") K965035 IMMAGE Immunochemistry Systems Microalbumin (MA) Reagent" further confirms its classification as an IVD, as it's being compared to another legally marketed IVD.
All these elements align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
N/A
Intended Use / Indications for Use
MA reagent, when used in conjunction with SYNCHRON CX® System(s) and SYNCHRON CX® MA Calibrator, is intended for quantitative determination of Albumin concentration in human urine. Measurement of albumin in urine aids in the diagnosis of kidney dysfunction.
Product codes
DCF
Device Description
Synchron Systems Microalbumin (MA) reagent is intended for the quantitative determination of albumin in urine. MA reagent is used to measure the albumin concentration by a turbidimetric method. In the reaction, albumin combines with specific antibody to form insoluble antigen-antibody complexes. The Synchron System(s) automatically proportions the appropriate sample and reagent volumes into the cuvette. The ratio used is one part sample to 24 parts reagent. The system monitors the change in absorbance at 380 nanometers. This change in absorbance is proportional to the concentration of albumin in the sample and is used by the system to calculate and express albumin concentration based upon a non-linear calibration curve.
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)
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, stability, linearity, and imprecision experiments.
Method Comparison Study Results:
Candidate: CX Systems Synchron Microalbumin (MA) Reagent (0.4 to 26.1 mg/L)
Slope: 0.990
Intercept: -0.11
R: 0.987
N: 111
Predicate Method: IMMAGE Microalbumin (MA) Reagent
SYNCHRON CX Systems Precision Study Results:
Within-Run Imprecision:
Level 1: Mean (mg/dL) 0.8, S.D. (mg/dL) 0.08, %C.V. 9.7, N 80
Level 2: Mean (mg/dL) 3.0, S.D. (mg/dL) 0.14, %C.V. 4.5, N 80
Level 3: Mean (mg/dL) 40.1, S.D. (mg/dL) 0.42, %C.V. 1.0, N 80
Total Imprecision:
Level 1: Mean (mg/dL) 0.8, S.D. (mg/dL) 0.13, %C.V. 16.3, N 80
Level 2: Mean (mg/dL) 3.0, S.D. (mg/dL) 0.23, %C.V. 7.5, N 80
Level 3: Mean (mg/dL) 40.1, S.D. (mg/dL) 0.59, %C.V. 1.5, N 80
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.5040 Albumin immunological test system.
(a)
Identification. An albumin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the albumin (a plasma protein) in serum and other body fluids. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases.(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 § 866.9.
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APR - 8 2009
Summary of Safety & Effectiveness SYNCHRON® Systems Microalbumin (MA) Reagent
1.0 Submitted By:
Marine Boyajian Senior Regulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd., W-110 Brea, California 92822-8000 Telephone: (714) 961-6536 FAX: (714) 961-4234
Date Submitted: 2.0
August 7, 2008
Device Name(s): 3.0
3.1 Proprietary Names SYNCHRON® Systems Microalbumin (MA) Reagent
3.2 Classification Name Albumin immunological test system (21 CFR § 866.5040)
Predicate Device: 4.0
| Candidate(s) | Predicate | Manufacturer | Docket
Number |
|-----------------------------------------------|----------------------------------------------------------------|-------------------------|------------------|
| Synchron Systems
Microalbumin (MA) Reagent | IMMAGE Immunochemistry
Systems Microalbumin (MA)
Reagent | Beckman
Coulter, Inc | K965035 |
5.0 Description:
Synchron Systems Microalbumin (MA) reagent is intended for the quantitative determination of albumin in urine. MA reagent is used to measure the albumin concentration by a turbidimetric method. In the reaction, albumin combines with specific antibody to form insoluble antigen-antibody complexes. The Synchron System(s) automatically proportions the appropriate sample and reagent volumes into the cuvette. The ratio used is one part sample to 24 parts reagent. The system monitors the change in absorbance at 380 nanometers. This change in absorbance is proportional to the concentration of albumin in the sample and is used by the system to calculate and express albumin concentration based upon a non-linear calibration curve.
6.0 Intended Use:
MA reagent, when used in conjunction with SYNCHRON CX® System(s) and SYNCHRON CX® MA Calibrator, is intended for the quantitative determination of albumin (MA) concentration in human urine. Measurement of albumin in urine aids in the diagnosis of kidney dysfunction.
Beckman Coulter, Inc., Section 510(k) Notification Page 1 of 2 SYNCHRON® Systems Microalbumin (MA) SYNCHRON® Systems Microalbumin (MA) Reagent, Revised SYN MA 510K_Summary 04.07.09 no LX.doc August, 2008
1
7.0 Comparison to Predicate(s):
| Similarities | ||
|---|---|---|
| Synchron | ||
| Microalbumin | ||
| (MA) Reagent | Intended Use | Same |
| Antibody | Goat anti-human albumin polyclonal Ab. | |
| Same as Immage MA Reagent | ||
| Buffer | Phosphate buffer with PEG | |
| Single point | ||
| adjusted | ||
| Calibration | MA on LX and DxC platforms and IMMAGE MA | |
| use single point adjusted non-linear calibration. | ||
| Differences | ||
| Synchron | ||
| Microalbumin | ||
| (MA) Reagent | Initial measuring | |
| range | Immage: 0.2 - 4.0 mg/dL | |
| Synchron Systems: 0.2 - 30 mg/dL | ||
| Extended | ||
| measuring range | Immage: 4.0 - 864.0 mg/dL | |
| (achieved via on-line dilutions) | ||
| Synchron Systems: 24 - 97 mg/dL | ||
| (achieved via smaller sample size) | ||
| Calibration | MA on Sychron CX systems uses 6 level non- | |
| linear calibration curve. |
The following table shows similarities and differences between the predicates identified in Section 4.0 of this summary.
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, stability, linearity, and imprecision experiments.
Method Comparison Study Results
| Candidate | Slope | Intercept | R | N | Predicate Method |
|---|---|---|---|---|---|
| CX Systems | |||||
| Synchron Microalbumin | |||||
| (MA) Reagent | |||||
| (0.4 to 26.1 mg/L) | 0.990 | -0.11 | 0.987 | 111 | IMMAGE |
| Microalbumin (MA) | |||||
| Reagent |
SYNCHRON CX Systems Precision Study Results
| Sample | Mean
(mg/dL) | S.D.
(mg/dL) | %C.V. | N |
|------------------------|-----------------|-----------------|-------|----|
| Within-Run Imprecision | | | | |
| Level 1 | 0.8 | 0.08 | 9.7 | 80 |
| Level 2 | 3.0 | 0.14 | 4.5 | 80 |
| Level 3 | 40.1 | 0.42 | 1.0 | 80 |
| Total Imprecision | | | | |
| Level 1 | 0.8 | 0.13 | 16.3 | 80 |
| Level 2 | 3.0 | 0.23 | 7.5 | 80 |
| Level 3 | 40.1 | 0.59 | 1.5 | 80 |
Beckman Coulter, Inc., Section 510(k) Notification Page 2 of 2 SYNCHRON® Systems Microalbumin (MA) SYNCHRON® Systems Microalbumin (MA) Reagent, Revised SYN MA 510K_Summary 04.07.09 no LX.doc
August, 2008
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three bars representing the agency's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Beckman Coulter Inc. c/o Ms. Marine Boyajian Senior Regulatory Affairs Specialist 200, South Kraemer Blvd W-110 Brea, CA 92822-8000
APR - 8 2009
K082251 Re:
Trade/Device Name: SYNCHRON Systems MicroAlbumin (MA) Reagent Regulation Number: 21 CFR 866.5040 Regulation Name: Albumin immunological test system Regulatory Class: Class II Product Code: DCF Dated: March 03, 2009 Received: March 04, 2009
Dear Ms. Boyajian:
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page - 2
This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In 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 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,
Coy. C. He
Courtney C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
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Indication for Use
510(k) Number (if known): K082251
Device Name: SYNCHRON® Systems Microalbumin (MA) Reagent
Indication For Use:
MA reagent, when used in conjunction with SYNCHRON CX® System(s) and SYNCHRON CX® MA Calibrator, is intended for quantitative determination of Albumin concentration in human urine. Measurement of albumin in urine aids in the diagnosis of kidney dysfunction.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Division Sig Off
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K082251