(105 days)
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No
The summary describes a standard enzymatic chemistry assay for uric acid and does not mention any AI or ML components.
No
The device is a diagnostic tool that quantifies uric acid levels, which aids in diagnosing and monitoring various conditions, but it does not directly treat or alleviate symptoms.
Yes
The device is intended for the "quantitative determination of uric acid in serum and plasma," and the "uric acid results are for the diagnosis and treatment of numerous renal and metabolic disorders." This directly indicates its use in diagnosing conditions.
No
The device description clearly states it is a "Reagent Kit" and a "Random Access Chemistry System," which are physical components used for chemical analysis. It also describes a chemical reaction and measurement of absorbance, indicating a hardware-based process.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "for the quantitative determination of uric acid in serum and plasma." 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 treatment.
- Device Description: The description details a chemical reaction used to measure uric acid in a sample, which is the core function of an in vitro diagnostic reagent.
- Sample Type: The device is intended for use with "serum and plasma," which are biological specimens.
- Purpose: The results are used for "the diagnosis and treatment of numerous renal and metabolic disorders," directly linking the test results to clinical decision-making.
- Predicate Device: The mention of a "Roche Uric Acid Reagent Kit" as a predicate device further confirms its classification as an IVD, as predicate devices are typically other legally marketed IVDs.
N/A
Intended Use / Indications for Use
The ATAC PAK Uric Acid Reagent Kit, the ATAC Calibrator and the ATAC 8000 Random Access Chemistry System are intended for use as a system for the quantitative determination of uric acid in serum and plasma. Unc acid results are for the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gour, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.
Product codes (comma separated list FDA assigned to the subject device)
KNK, JIX
Device Description
The ATAC PAK Uric Acid Reagent determines uric acid through the exzymatic oxidation coupled with a Trinder indicator reaction. The resulting increase in absorbance at 510 mm is proportional to the uric acid concentration of 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 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 effectiveness of ATAC PAK Uric Acid Reagent Kit on the ATAC 8000 Random Access Chemistry System is shown by the following studies.
The recovery of uric acid using the ATAC PAK Uric Acid Reagent is linear from 0.2 to 25 mg/dL, as shown by the recovery of linearity standards that span the usable range. Regression statistics, which are forced through the origin, compare standard recoveries to standard values. These statistics are shown below.
(ATAC Recoveries) = 0.996 x (Standard Value), r = 0.9998, sy.x = 0.18 mg/dL, n = 30
Precision is demonstrated by the replicate assay of commercially available control serum on two separate instruments. 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 | 2.3 | 0.12 | 5.0% | 0.23 | 9.8% |
| Serum 2 | 60 | 6.9 | 0.16 | 2.3% | 0.30 | 4.4% |
| Serum 3 | 60 | 11.3 | 0.19 | 1.7% | 0.38 | 3.4% |
Precision of Uric Acid Recoveries in mg/dr
Mixed serum and plasma speciments collected from adult patients were assayed for uric acid using the ATAC 8000 Random Access Chemistry System and another commercially available method. Results were compared by least squares linear regression and the following statistics were obtained.
ATAC 8000 = - 0.11 mg/dL + 0.987 x Competitive Reagent syx = 0.29 mg/dL n=120 range = 1.8 - 18.8 mg/dL
The detection limit of 0.2 mg/dL is documented the repetitive assay of a diluted serum pool. The observed standard deviation of a 30 replicate within run precision study was 0.1 mg/dL. Consequently, the detection limit is reported as twice the round-off error of the assay.
The 14 day on board reagent stablity claim is documented through the assay of serum controls over the claimed periods. In all cases, the observed change in control recoveries was less than 0.3 mg/dL.
The 3 day calibration stability claim is documented through the assay of serum controls over the claimed periods. In all cases, the total imprecision of wic acid recoveries over the test periods are less than 0.3 mg/dL or 5%.
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.
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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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§ 862.1775 Uric acid test system.
(a)
Identification. A uric acid test system is a device intended to measure uric acid in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.(b)
Classification. Class I (general controls). The device, when it is solely intended for use as an acid reduction of ferric ion test, a phosphotungstate reduction test, a gasometric uricase test, an ultraviolet uricase test, or an oxygen rate uricase test, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
JUL 15 2003
K 031044
Brea, CA 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 Uric Acid Reagent Kit is intended for the quantitative determination of uric acid in serum and plasma. Uric acid results are for the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gou, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs. The ATAC PAK Uric Acid Reagent determines uric acid through the exzymatic oxidation coupled with a Trinder indicator reaction. The resulting increase in absorbance at 510 mm is proportional to the uric acid concentration of the sample.
The ATAC PAK Uric Acid Reagent Kit and ATAC Calibrator are substantially equivalent to the Roche Uric Acid Reagent Kit, product no. 908241 callbrated with the C.f.a.s. Calibrator, product no. 759350, which are marked by Roche Diagnostics of Indianapolis, IN. The effectiveness of ATAC PAK Uric Acid Reagent Kit on the ATAC 8000 Random Access Chemistry System is shown by the following studies.
The recovery of uric acid using the ATAC PAK Uric Acid Reagent is linear from 0.2 to 25 mg/dL, as shown by the recovery of linearity standards that span the usable range. Regression statistics, which are forced through the origin, compare standard recoveries to standard values. These statistics are shown below.
(ATAC Recoveries) = 0.996 x (Standard Value), r = 0.9998, sy.x = 0.18 mg/dL, n = 30
Precision is demonstrated by the replicate assay of commercially available control serum on two separate instruments. 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 | 2.3 | 0.12 | 5.0% | 0.23 | 9.8% |
| Serum 2 | 60 | 6.9 | 0.16 | 2.3% | 0.30 | 4.4% |
| Serum 3 | 60 | 11.3 | 0.19 | 1.7% | 0.38 | 3.4% |
Precision of Uric Acid Recoveries in mg/dr
Mixed serum and plasma speciments collected from adult patients were assayed for uric acid using the ATAC 8000 Random Access Chemistry System and another commercially available method. Results were compared by least squares linear regression and the following statistics were obtained.
ATAC 8000 = - 0.11 mg/dL + 0.987 x Competitive Reagent syx = 0.29 mg/dL n=120 range = 1.8 - 18.8 mg/dL
The detection limit of 0.2 mg/dL is documented the repetitive assay of a diluted serum pool. The observed standard deviation of a 30 replicate within run precision study was 0.1 mg/dL. Consequently, the detection limit is reported as twice the round-off error of the assay.
The 14 day on board reagent stablity claim is documented through the assay of serum controls over the claimed periods. In all cases, the observed change in control recoveries was less than 0.3 mg/dL.
The 3 day calibration stability claim is documented through the assay of serum controls over the claimed periods. In all cases, the total imprecision of wic acid recoveries over the test periods are less than 0.3 mg/dL or 5%.
Wynn Stocking
Manager of Regulatory Affairs July 11, 2003
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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 image of three human profiles facing right, with flowing lines suggesting movement or progress.
JUL 15 2003
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Wynn Stocking Manager, Regulatory Affairs Elan Diagnostics 1075 W. Lambert Road - Building D Brea. CA 92821
Re: K031044
Trade/Device Name: ATAC PAK Uric Acid Reagent Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: KNK: JIX Dated: March 31, 2003 Received: April 30, 2003
Dear Mr. Stocking:
We have reviewed vour 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 vours.
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
ﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ �
3
Kosioitt
510(k) Number (if known):
Device Name:
ATAC PAK Uric Acid Reagent
Indications for Use:
The ATAC PAK Uric Acid Reagent Kit, the ATAC Calibrator and the ATAC 8000 Random Access Chemistry System are intended for use as a system for the quantitative determination of uric acid in serum and plasma. Unc acid results are for the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gour, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.
This reagent is intended to be used by trained personnel in a professional setting and is not intended for home use.
Division Sign-Off
Office of In Vitro Diagnostic Device
Evaluation and Safety
510(k) K031014
Division Sign-Off
Office of In Vitro Diagnostic Device
Evaluation and Safety
510(k)
(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)