(64 days)
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No
The device is a chemical reagent kit for a chemistry analyzer, relying on a standard chemical reaction and absorbance measurement. There is no mention of AI/ML in the description, intended use, or performance studies.
No
Explanation: This device is a reagent kit used for the quantitative determination of inorganic phosphorus in serum and plasma, which is a diagnostic function, not a therapeutic one.
Yes
The ATAC PAK Phosphorus Reagent Kit is explicitly stated as providing "quantitative determination of inorganic phosphorus in serum and plasma," and the "Phosphorus results are used for the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance." This clearly indicates its role in aiding diagnosis.
No
The device is a reagent kit, which is a chemical substance used in a laboratory test. It is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the kit is for the "quantitative determination of inorganic phosphorus in serum and plasma." This is a classic definition of an in vitro diagnostic test, as it analyzes biological samples outside of the body to provide information for diagnosis and treatment.
- Device Description: The description details how the reagent interacts with the sample (reaction with molybdate) to produce a measurable result (increase in absorbance). This process is performed in vitro (in a test tube or similar container).
- Performance Studies: The document describes studies evaluating the performance of the reagent kit in analyzing samples, including linearity, precision, and method comparison. These are typical studies conducted for IVD devices to demonstrate their analytical performance.
N/A
Intended Use / Indications for Use
The ATAC PAK Phosphorus Reagent Kit is intended for the quantitative determination of inorganic phosphorus in serum and plasma. Phosphorus results are used for the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.
The ATAC PAK Phosphorus 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 inorganic phosphorus in serum and plasma. Phosphorus results are used for the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.
Product codes (comma separated list FDA assigned to the subject device)
CEO
Device Description
The ATAC PAK Phosphorus Reagent determines phosphorus through its reaction with molybdate to form a phosphomolybdate complex. The resulting increase in absorbance at 340 nm is proportional to the phosphorus 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
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Intended User / Care Setting
This reagent is intended to be used by 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 inorganic phosphorus using the ATAC PAK Phosphorus Reagent is linear from 0.1 to 15 mg/dL. as shown by the recovery of linearity standards that span the usable range. Regression statistics compare stoneries to standard values. These statistics are shown below.
(ATAC Recoveries) = -0.05 mg/dL + 0.991 x (Standard Value), r = 1.000, sYX = 0.11 mg/dL, n = 27% of the rod
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 | 1.8 | 0.06 | 3.2% | 0.09 | 5.0% |
| Serum 2 | 60 | 4.3 | 0.10 | 2.3% | 0.15 | 3.5% |
| Serum 3 | 60 | 6.7 | 0.15 | 2.3% | 0.23 | 3.5% |
Mixed serum and plasma specimens, collected from adult patients, were assayed for inorganic phosphorus 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 = -0.17 mg/dL + 1.001 x Competitive Reagent sv.x= 0.17 mg/dL n = 115 range = 0.9 - 9.6 mg/dL
The detection limit of 0.1 mg/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 0.049 mg/dL. Consequently, the detection limit is reported as 0.1 mg/dL, which is 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 phosphorus over the test periods are less than 0.2 mg/dL or 4%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Linearity: 0.1 to 15 mg/dL
Detection limit: 0.1 mg/dL
Stability: 14 day onboard reagent stability, 7 day calibration stability
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.
Beckman Synchron Phosphorus Reagent, product 465145
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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§ 862.1580 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.
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MAR 0 7 2003
Image /page/0/Picture/2 description: The image shows the word "élan" in a stylized font. The "é" has a textured design above it, resembling a brushstroke or abstract mark. The rest of the word "lan" is written in a simple, elegant typeface, contrasting with the more decorative "é".
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 Phosphorus Reagent Kit is intended for the quantitative determination of inorganic phosphorus in serum and plasma. Phosphorus results are used for the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance. The ATAC PAK Phosphorus Reagent determines phosphorus through its reaction with molybdate to form a phosphomolybdate complex. The resulting increase in absorbance at 340 nm is proportional to the phosphorus concentration in the sample.
The ATAC PAK Phosphorus Reagent Kit is substantially equivalent to the Beckman Synchron Phosphorus Reagent, product 465145, which is currently marketed by Beckman Coulter, Inc. of Brea, CA. The effectiveness of ATAC PAK Phosphorus Reagent Kit on the ATAC 8000 Random Access Chemistry System is shown by the following studies.
The recovery of inorganic phosphorus using the ATAC PAK Phosphorus Reagent is linear from 0.1 to 15 mg/dL. as shown by the recovery of linearity standards that span the usable range. Regression statistics compare stoneries to standard values. These statistics are shown below.
$$\text{(ATAC Recoveries)} = -0.05 \text{ mg/dL} + 0.991 \times \text{(Standard Value)}, \quad \text{r} = 1.000, \quad \text{s}_{\text{Y}\text{X}} = 0.11 \text{ mg/dL}, \quad \text{n} = 27% \text{ of the rod}$$
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 | 1.8 | 0.06 | 3.2% | 0.09 | 5.0% |
| Serum 2 | 60 | 4.3 | 0.10 | 2.3% | 0.15 | 3.5% |
| Serum 3 | 60 | 6.7 | 0.15 | 2.3% | 0.23 | 3.5% |
Mixed serum and plasma specimens, collected from adult patients, were assayed for inorganic phosphorus 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 = -0.17 mg/dL + 1.001 x Competitive Reagent sv.x= 0.17 mg/dL n = 115 range = 0.9 - 9.6 mg/dL
The detection limit of 0.1 mg/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 0.049 mg/dL. Consequently, the detection limit is reported as 0.1 mg/dL, which is 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 phosphorus over the test periods are less than 0.2 mg/dL or 4%.
Wynn Stocking
Wynn Stocking Manager of Regulatory Affairs Elan, Brea California
510(k) Notification, ATAC PAK Phosphorus Reagent Kit, 31 December, 2002, p 63
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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 depiction of an eagle or bird with three curved lines representing its wings or feathers. The bird is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle. The logo is rendered in black and white.
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
K030015 Trade/Device Name: ATAC PAK Phosphorus Reagent Regulation Number: 21 CFR 862.1580 Regulation Name: Phosphorus (inorganic) test system Regulatory Class: Class I Product Code: CEO Dated: December 31, 2002 Received: January 2, 2003
Dear Mr. Stocking:
Re:
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. Iisting 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 Putman
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
KosoonS
510(k) Number (if known):
Device Name:
ATAC PAK Phosphorus Reagent
Indications for Use:
The ATAC PAK Phosphorus 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 inorganic phosphorus in serum and plasma. Phosphorus results are used for the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.
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)
Jean Coope
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K630015
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)