(55 days)
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No
The document describes a chemical reagent for quantitative determination of total protein, not a software or algorithm-based device. There is no mention of AI or ML.
No
Explanation: This device is an in vitro diagnostic reagent used for the quantitative determination of total protein, which aids in diagnosis and treatment monitoring, but does not directly provide therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that "Total protein results are used in the diagnosis and treatment of a variety of diseases".
No
The device is a reagent, which is a chemical substance used in a laboratory test, not a software program.
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 total protein in serum and plasma" and "serum, plasma and cerebrospinal fluid". These are biological samples taken from the human body.
- Purpose: The results are used "in the diagnosis and treatment of a variety of diseases". This directly aligns with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description: The description reiterates the intended use of determining total protein in biological fluids.
- Professional Use: While it mentions "professional use only," this is common for IVDs that require trained personnel to operate and interpret the results.
Therefore, based on the provided information, the HiChem® Total Protein Reagent clearly fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
HiChem® Total Protein Reagent is intended for the quantitative determination of total protein in serum and plasma on the SYNCHRON CX® Systems and serum, plasma and cerebrospinal fluid on the SYNCHRON CX® DELTA Systems. Total protein results are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders. This reagent is intended for professional use only.
Product codes
CEK
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
professional use only
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Precision: Serum and cerebrospinal fluid controls were each assayed 3 times per 10 days using HiChem® and Beckman® total protein reagents on a SYNCHRON CX® DELTA System. Estimates of within run and total imprecision were calculated as described in NCCLS publication EP3-T.
Patient Comparison: Serum, plasma and CSF specimens, collected from adult patients, were assayed using HiChem® and Beckman® total protein reagents on a SYNCHRON CX® DELTA System. Results were compared by least squares linear regression.
Key Metrics
Precision:
Serum 1: HiChem® Reagent Within Run 1SD 0.04, %CV 1.1%; Total 1SD 0.06, %CV 1.7%. Beckman® Reagent Within Run 1SD 0.04, %CV 1.2%; Total 1SD 0.05, %CV 1.3%.
Serum 2: HiChem® Reagent Within Run 1SD 0.04, %CV 0.7%; Total 1SD 0.08, %CV 1.3%. Beckman® Reagent Within Run 1SD 0.04, %CV 0.8%; Total 1SD 0.06, %CV 1.0%.
Serum 3: HiChem® Reagent Within Run 1SD 0.05, %CV 0.7%; Total 1SD 0.11, %CV 1.4%. Beckman® Reagent Within Run 1SD 0.05, %CV 0.6%; Total 1SD 0.09, %CV 1.1%.
CSF 1: HiChem® Reagent Within Run 1SD 3.17, %CV 15.2%; Total 1SD 4.11, %CV 19.7%. Beckman® Reagent Within Run 1SD 1.09, %CV 5.2%; Total 1SD 2.58, %CV 12.2%.
CSF 2: HiChem® Reagent Within Run 1SD 1.62, %CV 3.1%; Total 1SD 2.31, %CV 4.4%. Beckman® Reagent Within Run 1SD 1.52, %CV 2.8%; Total 1SD 2.79, %CV 5.2%.
Patient Comparison:
Serum/Plasma Comparison: HiChem® = 0.2 g/dL + 0.970 x Beckman® Reagent r = 0.988 n = 160 range = 4.6 - 8.6 g/dL
CSF Comparison: HiChem® = -2.8 mg/dL + 1.010 x Beckman® Reagent r = 0.995 n = 40 range = 11 - 332 mg/dL
Predicate Device(s)
SYNCHRON® CX® Systems Total Protein Reagent Kit, product no. 450224
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.1635 Total protein test system.
(a)
Identification. A total protein test system is a device intended to measure total protein(s) in serum or plasma. Measurements obtained by this device are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders.(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 § 862.9.
0
KG9284L
OCT 18 100 5
élan diagnostics
Image /page/0/Picture/3 description: The image is a black and white logo for "élan". The logo features a stylized letter "e" formed by three parallel curved lines, with three short, horizontal lines extending from the left side of the "e", suggesting movement or speed. Below the symbol is the word "élan" in a simple, sans-serif typeface.
Summary of 510(k) Safety and Effectiveness Information
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
HiChem® Total Protein Reagent is intended for the quantitative determination of total protein in serum and plasma on the SYNCHRON CX® Systems and serum, plasma and cerebrospinal fluid on the SYNCHRON CX® DELTA Systems. The HiChem® Total Protein Reagent Kit is substantially equivalent to the SYNCHRON® CX® Systems Total Protein Reagent Kit, product no. 450224, manufactured by Beckman Coulter, Inc.
The effectiveness of the Total Protein Reagent Kit is shown by the following studies.
Precision:
Serum and cerebrospinal fluid controls were each assayed 3 times per 10 days using HiChem® and Beckman® total protein reagents on a SYNCHRON CX® DELTA System. Estimates of within run and total imprecision were calculated as described in NCCLS publication EP3-T.
Precision of Total Protein Recoveries
| Sample | unit | n | mean | HiChem® Reagent
Within Run | | | Total | | n | mean | Beckman® Reagent
Within Run | | | Total | |
|---------|-------|----|------|-------------------------------|-------|--|-------|-------|----|------|--------------------------------|------|--|-------|-------|
| | | | | 1SD | %CV | | 1SD | %CV | | | 1SD | %CV | | 1SD | %CV |
| Serum 1 | g/dL | 60 | 3.8 | 0.04 | 1.1% | | 0.06 | 1.7% | 60 | 3.8 | 0.04 | 1.2% | | 0.05 | 1.3% |
| Serum 2 | g/dL | 60 | 5.9 | 0.04 | 0.7% | | 0.08 | 1.3% | 60 | 5.9 | 0.04 | 0.8% | | 0.06 | 1.0% |
| Serum 3 | g/dL | 60 | 8.0 | 0.05 | 0.7% | | 0.11 | 1.4% | 60 | 8.0 | 0.05 | 0.6% | | 0.09 | 1.1% |
| CSF 1 | mg/dL | 60 | 21 | 3.17 | 15.2% | | 4.11 | 19.7% | 60 | 21 | 1.09 | 5.2% | | 2.58 | 12.2% |
| CSF 2 | mg/dL | 60 | 53 | 1.62 | 3.1% | | 2.31 | 4.4% | 60 | 54 | 1.52 | 2.8% | | 2.79 | 5.2% |
Patient Comparison:
Serum, plasma and CSF specimens, collected from adult patients, were assayed using HiChem® and Beckman® total protein reagents on a SYNCHRON CX® DELTA System. Results were compared by least squares linear regression and the following statistics were obtained.
Serum/Plasma Comparison
HiChem® = 0.2 g/dL + 0.970 x Beckman® Reagent r = 0.988 n = 160 range = 4.6 - 8.6 g/dL CSF Comparison HiChem® = -2.8 mg/dL + 1.010 x Beckman® Reagent r = 0.995 n = 40 range = 11 - 332 mg/dL
Wynn Stocking
Wynn Stocking Manager of Regulatory Affairs Elan Diagnostics
20 August, 1999
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 1 8 1999
Mr. Wynn Stocking Manager, Regulatory Affairs Elan Diagnostics 231 North Puente Street Brea. California 92821
Re: K992846
Trade Name: HiChem® Total Protein Reagent Regulatory Class: II Product Code: CEK Dated: August 20, 1999 Received: August 24, 1999
Dear Mr. Stocking:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include reguirements 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 (Premarket Approval), 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 895, A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrl/dsma/dsmamain.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
3
510(k) Number (if known):
Device Name:
HiChem® Total Protein Reagent
Indications For Use:
HiChem® Total Protein Reagent is intended for the quantitative determination of total protein in serum and DRSma on the Hollen "Total Froten Frought formation of and cerebrospinal fluid on the SYNCHRON CX® DELTA Systems.
SYNCHRON CX® Systems and serum, plasma and cerebrospinal fluid on the SYN
Total protein results are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders.
This reagent is intended for professional use only.
Respectfully,
Wyquin Stocking
Wynn Stocking Regulatory Affairs Manager Elan Diagnostics
20 August, 1999
Sean Cooper
(Division Sign-Off)
Division, Clinical Laboratory Devices
510(k) Number: K992846
(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)
510(k) Notification, HiChem® Total Protein Reagent Elan Diagnostics, Brea; California