(64 days)
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No
The description focuses on a chemical reaction and absorbance measurement, with no mention of AI or ML.
No.
The device is a reagent kit used for the quantitative determination of albumin, which is a diagnostic tool, not a therapeutic device.
Yes
This device is intended for the quantitative determination of albumin in serum and plasma, and the results are used for the diagnosis and treatment of diseases primarily involving the liver or kidneys. This directly aligns with the definition of a diagnostic device as it aids in the diagnosis of medical conditions.
No
The device is a reagent kit, which is a chemical substance used in a laboratory test. It is explicitly described as a "Reagent Kit" and its mechanism of action involves a chemical reaction (selective binding of bromcresol green) and measurement of absorbance, indicating a physical component and process, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "for the quantitative determination of albumin in serum and plasma." This indicates it's used to analyze samples taken from the body (in vitro) to provide diagnostic information.
- Device Description: The description further clarifies that it determines albumin in serum and plasma and that the results are used for "diagnosis and treatment of numerous diseases."
- Mechanism: The device uses a chemical reaction (selective binding of bromcresol green) to measure a substance in a biological sample, which is a hallmark of an in vitro diagnostic test.
- Performance Studies: The performance studies describe the evaluation of the device's ability to accurately and precisely measure albumin in serum and plasma samples.
- Predicate Device: The mention of a "Predicate Device" (Roche Albumin Reagent Kit) is common in regulatory submissions for IVDs, indicating a comparison to an already approved IVD.
All these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ATAC PAK Albumin Reagent Kit is intended for the quantitative determination of albumin in serum and plasma. Albumin results are used for the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.
The ATAC PAK Albumin Reagent Kit is intended for use with the ATAC Calibrator and the ATAC 8000 Random Access Chemistry System as a system for the quantitative determination of albumin in serum and plasma. Albumin results are used for the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.
Product codes (comma separated list FDA assigned to the subject device)
CIX
Device Description
The ATAC PAK Albumin Reagent determines albumin by the selective binding of bromcresol green. The resulting increase in absorbance at 630 nm is proportional to the albumin concentration in the sample.
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
adult patients
Intended User / Care Setting
trained personnel in a professional setting and is not intended for home use.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The recovery of albumin using the ATAC PAK Albumin Reagent is linear from 0.1 to 8 g/dL, as shown by the recovery of linearity standards that span the usable range. Regression statistics compare standard values. These statistics are shown below. (ATAC Recoveries) = 0.04 g/dL + 0.902 x (Reference Value), r = 0.999, Sy.x = 0.11 g/dL, n = 33.
Precision is demonstrated by the replicate assay of commercially available control serum. Precision statistics, calculated analogous to the method described in NCCLS Guideline EP3-T, are shown below.
Serum 1: n=60, mean=2.5, Within Run 1SD=0.06, %CV=2.5%; Total 1SD=0.08, %CV=3.3%.
Serum 2: n=60, mean=3.9, Within Run 1SD=0.09, %CV=2.3%; Total 1SD=0.11, %CV=2.8%.
Serum 3: n=60, mean=5.3, Within Run 1SD=0.09, %CV=1.6%; Total 1SD=0.12, %CV=2.3%.
Mixed serum and plasma specimens, collected from adult patients, were assayed for albumin using the ATAC 8000 Random Access Chemistry System and another commercially available method. Results were compared by Deming regression and the following statistics were obtained. ATAC 8000 = 0.5 g/dL + 0.867 x Competitive Reagent range = 1.9 - 5.4 g/dL Sy.x = 0.11 g/dL n = 119.
The detection limit of 0.1 g/dL is documented through the repetitive assay of a diluted serum pool. The observed standard deviation of a 30 replicate within run precision study was 0.018 g/dL.
The 14 day onboard reagent stability and 7 day calibration stability claims are documented through the assay of serum controls over the claimed periods. In all cases, the total imprecision of albumin recoveries over the test than 0.15 g/dL or 3%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Roche Albumin Reagent Kit, product no. 1970569
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 862.1035 Albumin test system.
(a)
Identification. An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image shows the text "K030006 MAR 07 2003". The top line appears to be a code or identifier, while the bottom line represents a date. The date is formatted as month, day, and year.
Image /page/0/Picture/1 description: The image shows a logo with the word "élan" in a stylized font. The "é" has a unique design, with the accent mark resembling a flame or a brushstroke. The rest of the letters are in a simple, elegant typeface. The logo is in black and white.
1075 W. Lambert Road Building D Brea, California 92821 T (714) 672 3553 F (714) 672 3554
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.
The ATAC PAK Albumin Reagent Kit is intended for the quantitative determination of albumin in serum and plasma. Albumin results are used for the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys. The ATAC PAK Albumin Reagent determines albumin by the selective binding of bromcresol green. The resulting increase in absorbance at 630 nm is proportional to the albumin concentration in the sample.
The ATAC PAK Albumin Reagent Kit is substantially equivalent to the Roche Albumin Reagent Kit, product no. 1970569, which is marketed by Roche Diagnostics of Indianapolis, IN. The effectiveness of ATAC PAK Albumin Reagent Kit on the ATAC 8000 Random Access Chemistry System is shown by the following studies.
The recovery of albumin using the ATAC PAK Albumin Reagent is linear from 0.1 to 8 g/dL, as shown by the recovery of linearity standards that span the usable range. Regression statistics compare standard values. These statistics are shown below.
(ATAC Recoveries) = 0.04 g/dL + 0.902 x (Reference Value), r = 0.999, Sy.x = 0.11 g/dL, n = 33
Precision is demonstrated by the replicate assay of commercially available control serum. Precision statistics, calculated analogous to the method described in NCCLS Guideline EP3-T, are shown below.
| Sample | n | mean | Within Run | Total | ||
|---|---|---|---|---|---|---|
| 1SD | %CV | 1SD | %CV | |||
| Serum 1 | 60 | 2.5 | 0.06 | 2.5% | 0.08 | 3.3% |
| Serum 2 | 60 | 3.9 | 0.09 | 2.3% | 0.11 | 2.8% |
| Serum 3 | 60 | 5.3 | 0.09 | 1.6% | 0.12 | 2.3% |
Mixed serum and plasma specimens, collected from adult patients, were assayed for albumin using the ATAC 8000 Random Access Chemistry System and another commercially available method. Results were compared by Deming regression and the following statistics were obtained.
ATAC 8000 = 0.5 g/dL + 0.867 x Competitive Reagent range = 1.9 - 5.4 g/dL Sy.x = 0.11 g/dL n = 119
The detection limit of 0.1 /dL is documented through the repetitive assay of a diluted serum pool. The observed standard deviation of a 30 replicate within run precision study was 0.018 g/dL. Consequently, the detection limit is reported as the round-off error of the assay.
The 14 day onboard reagent stability and 7 day calibration stability claims are documented through the assay of serum controls over the claimed periods. In all cases, the total imprecision of albumin recoveries over the test than 0.15 g/dL or 3%.
Wynne Stocking
Wynne Stocking
Wynn Stocking Manager of Regulatory Affairs Elan, Brea California
510(k) Notification, ATAC PAK Albumin Reagent Kit, 31 December, 2002, p 55
Image /page/0/Picture/19 description: The image shows a black and white drawing of a winding path through a dense forest. The path is light in color and contrasts with the dark, textured foliage on either side. The path appears to lead towards a distant point, creating a sense of depth within the image. The drawing style is somewhat detailed, capturing the complexity of the forest environment.
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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, with flowing lines suggesting movement or progress.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 0 7 2003
Mr. Wynn Stocking Manager, Regulatory Affairs Elan Diagnostics 1075 W. Lambert Road - Building D Brea. CA 92821
Re: K030006 Trade/Device Name: ATAC PAK Albumin Reagent Regulation Number: 21 CFR 862.1035 Regulation Name: Albumin test system Regulatory Class: Class II Product Code: CIX Dated: December 31, 2002 Received: January 2, 2003
Dear Mr. Stocking:
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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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,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known):
Device Name:
ATAC PAK Albumin Reagent
Indications for Use:
The ATAC PAK Albumin Reagent Kit is intended for use with the ATAC Calibrator and the ATAC 8000 Random Access Chemistry System as a system for the quantitative determination of albumin in serum and plasma. Albumin results are used for the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.
This reagent is intended to be used by trained personnel in a professional setting and is not intended for home use.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number ×630006
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)