(50 days)
Not Found
product no. 1930672, product no. 1972235
No
The description focuses on enzymatic and photometric methods for determining HDL-cholesterol concentration, with no mention of AI or ML.
No
The device is an in vitro diagnostic (IVD) reagent kit used for the quantitative determination of HDL-cholesterol, which aids in diagnosis and treatment monitoring, but it does not directly treat a condition or restore function.
Yes
The "Intended Use / Indications for Use" section explicitly states that "HDL-cholesterol results are used in the diagnosis and treatment of lipid disorders... atherosclerosis, and various liver and renal diseases, and for the risk of developing cardiovascular disease." This indicates the device provides information crucial for diagnosis.
No
The device description clearly indicates it is a reagent kit and a chemistry system, which are physical components used for chemical analysis, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the kit is for the "quantitative determination of HDL-cholesterol in serum and plasma." Serum and plasma are biological specimens taken from the human body.
- Purpose: The results are used "in the diagnosis and treatment of lipid disorders... atherosclerosis, and various liver and renal diseases, and for the risk of developing cardiovascular disease." This clearly indicates a medical purpose related to diagnosing and managing health conditions.
- Device Description: The description details how the device works by performing enzymatic reactions on the sample to measure a specific analyte (HDL-cholesterol). This is a typical characteristic of an in vitro diagnostic test.
- Specimen Type: The device uses "serum and plasma," which are human biological specimens.
- Setting: It is intended for use by "trained personnel in a professional setting," which aligns with the typical use of IVDs in laboratories or clinical environments.
All these factors strongly indicate that this device is designed to be used outside of the body (in vitro) to examine specimens from the human body for the purpose of providing information for diagnosis, treatment, or monitoring of health conditions.
N/A
Intended Use / Indications for Use
The ATAC PAK Direct HDL Reagent Kit, the ATAC Direct HDL Calibrator and the ATAC 8000 Random Access Chemistry System are intended for use as a system for the quantitative determination of HDL-cholesterol in serum and plasma. HDL-cholesterol results are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases, and for the risk of developing cardiovascular disease.
Product codes
JIS, LBS
Device Description
The ATAC PAK Direct HDL Reagent determines HDL-cholesterol through the enzymatic action of cholesterol esterase and cholesterol oxidase, with cholesterol oxidase converting only the HDL-cholesterol fraction to produce a measurable change, while other sources of cholesterol are inactive. The resulting increase in absorbance at approximately 600 nm is proportional to the HDL-cholesterol concentration in the sample.
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
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
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The effectiveness of ATAC PAK Direct HDL Reagent Kit and the ATAC Direct HDL used on the ATAC 8000 Random Access Chemistry System is shown by the following studies.
Linearity: The recovery of HDL-cholesterol using the ATAC PAK Direct HDL Reagent is linear from 10 to 140 mg/dL as shown by the recovery of linearity standards that span the usable range. Linear regression statistics, with the regression line forced through the origin, compare standard recoveries to standard factors.
(ATAC Recoveries) = 0 mg/dL + 0.9570 x (Standard Factors), s(y.x) = 4.5 mg/dL, n = 40 r = 0.995.
Precision: Precision is demonstrated by the replicate assay of commercially available control serum and a serum pool. Precision statistics, calculated analogous to the method described in NCCLS Guideline EP3-T, are shown below.
| Sample | n | mean | Within Run 1SD | Within Run %CV | Total 1SD | Total %CV |
|---|---|---|---|---|---|---|
| Serum 1 | 66 | 26 | 1.0 | 3.8% | 1.9 | 7.4% |
| Serum 2 | 66 | 55 | 1.5 | 2.8% | 2.8 | 5.1% |
| Serum 3 | 66 | 68 | 2.0 | 2.9% | 2.7 | 3.9% |
Method Comparison: Mixed serum and plasma specimens, collected from adult patients, were assayed for HDL-cholesterol using the ATAC 8000 Random Access Chemistry System and another commercially available method. Results were compared by regression and the following statistics were obtained.
Serum/Plasma Comparison ATAC 8000 = 2.8 mg/dL + 0.912 x Competitive Reagent range = 4.7 - 123 mg/dL r = 0.978 n = 156
Detection Limit: The detection limit claim of 10 mg/dL is documented through the repetitive assay of a diluted serum pool. The observed detection limit, calculated as two standard deviations of a 30 replicate within run precision study, is 1.5 mg/dL and is below the claimed limit.
Stability: The 30 day on board reagent stability and 14 day calibration stability claims are documented through the assay of serum controls over the claimed periods. In all cases, the total imprecision of HDL-cholesterol recoveries over the test periods are less than 3 mg/dL or 6%.
Key Metrics
Linearity: r = 0.995
Precision:
- Serum 1: Within Run 3.8% CV, Total 7.4% CV
- Serum 2: Within Run 2.8% CV, Total 5.1% CV
- Serum 3: Within Run 2.9% CV, Total 3.9% CV
Method Comparison: r = 0.978
Detection Limit: 1.5 mg/dL
Predicate Device(s)
Not Found
Reference Device(s)
Roche HDL-Cholesterol plus Reagent Kit, product no. 1930672, calibrated with Roche C.f.a.s HDL/LDL-C plus calibrator, product no. 1972235
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1475 Lipoprotein test system.
(a)
Identification. A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.(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 § 862.9.
0
élan diagnostics
Image /page/0/Picture/1 description: The image shows a logo for "élan". The logo features a stylized letter "e" formed by several curved lines, with a series of horizontal lines extending from the left side of the "e", resembling motion lines. Below the symbol is the word "élan" in a bold, sans-serif font, with an acute accent over the "e".
K013/52
SUMMARY OF 510(K) SAFETY AND EFFECTIVENESS INFORMATION
NOV 0 9 2001
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 Direct HDL Reagent Kit, the ATAC Direct HDL Calibrator and the ATAC 8000 Random Access THE ATAC PAR DIFOR INDE ROLE AS a system for the quantitative determination of HDL-cholesterol in serum and Chemisty System are intended for ass a a Frientis and treatment of lipid disorders (such as diabetes mellius), plasma. HDL-cholesteros results and renal diseases, and for the assessment of the risk of developing cardiovascular disease.
The ATAC PAK Direct HDL Reagent determines HDL-cholesterol through the enzymatic action of cholesterol esterase and The HIAC ITAN Dates 1122 Nother sources of cholesterol inactive. The resulting increase in absorbance at approximately 600 nm is proportional to the HDL-cholesterol concentration in the sample.
The ATAC PAK Direct HDL Reagent Kit, calibrated with the ATAC Direct HDL Calibrator, is substantially equivalent to the Roche HDL-Cholesterol plus Reagent Kit, product no. 1930672, calibrated with Roche C.f.a.s HDL/LDL-C plus calibrator, product no. 1972235, which are currently marketed by Roche Inc. of Indianapolis, IN.
The effectiveness of ATAC PAK Direct HDL Reagent Kit and the ATAC Direct HDL used on the ATAC 8000 Random Access Chemistry System is shown by the following studies.
The recovery of HDL-cholesterol using the ATAC PAK Direct HDL Reagent is linear from 10 to 140 mg/dL as shown by the recovery of linearity standards that span the usable range. Linear regression statistics, with the regression line forced through the origin, compare standard recoveries to standard factors.
(ATAC Recoveries) = 0 mg/dL + 0.9570 x (Standard Factors), sv.x = 4.5 mg/dL, n = 40 r = 0.995.
Precision is demonstrated by the replicate assay of commercially available control serum and a serum pool. 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 | 66 | 26 | 1.0 | 3.8% | 1.9 | 7.4% |
| Serum 2 | 66 | 55 | 1.5 | 2.8% | 2.8 | 5.1% |
| Serum 3 | 66 | 68 | 2.0 | 2.9% | 2.7 | 3.9% |
Mixed serum and plasma specimens, collected from adult patients, were assayed for HDL-cholesterol using the ATAC 8000 Random Access Chemistry System and another commercially available method. Results were compares regression and the following statistics were obtained.
Serum/Plasma Comparison ATAC 8000 = 2.8 mg/dL + 0.912 x Competitive Reagent range = 4.7 - 123 mg/dL r = 0.978 n = 156
510(k) Notification, ATAC PAK Direct HDL Reagent Kit, 19 Sept., 2001, p 49
Elan Diagnostics 1075 W. Lambert Road · Brea California 92821 Phone: 714.672.3553 · Fax: 714.672.3554
1
The detection limit claim of 10 mg/dL is documented through the repetitive assay of a diluted serum pool. The observed detection limit, calculated as two standard deviations of a 30 replicate within run precision study, is 1.5 mg/dL and is below the claimed limit.
The 30 day on board reagent stability and 14 day calibration stability claims are documented through the assay of serum controls over the claimed periods. In all cases, the total imprecision of HDL-cholesterol recoveries over the test periods are less than 3 mg/dL or 6%.
Wynn Storking
Wynn Storking
Wynn Stocking Manager of Regulatory Affairs Elan Diagnostics
510(k) Notification, ATAC PAK Direct HDL Reagent Kit, 19 Sept., 2001, p 50
Elan Diagnostics 1075 W. Lambert Road · Brea California 92821 Phone: 714.672.3553 · Fax: 714.672.3554
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three stripes forming its body and head. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 0 9 2001
Mr. Wynn Stocking Manager, Regulatory Affairs Elan Diagnostics 1075 W. Lambert Road Brea, CA 92821
Re: K013152
Trade/Device Name: ATAC PAK Direct HDL Reagent; ATAC Direct HDL Calibrator Regulation Number: 21 CFR 862.1150; : 21 CFR 862.1475 Regulation Name: Calibrator; Lipoprotein test system Regulatory Class: Class II; Class I, reserved Product Code: JIS; LBS Dated: September 19, 2001 Received: September 20, 2001
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 -
This letter will allow you to begin marketing your device as described in your 510(k) premarket I mis letter will and wyou would of substantial equivalence of your device to a legally marketed nouticate 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 1 IT you desire specific an 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, (201) 59 react the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mornation on your respond and Consumer Assistance at its toll-free number (800) 638-2041 or 1901) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
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
4
NOV 0 9 2001
510(k) Number (if known):
ATAC PAK Direct HDL Reagent and ATAC Direct HDL Calibrator
Indications For Use:
Device Name:
The ATAC PAK Direct HDL Reagent Kit, the ATAC Direct HDL Calibrator and the ATAC 8000 Random Access Chemistry System are intended for use as a system for the quantitative determination of HDL-cholesterol in serum and plasma. HDL-cholesterol results are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases, and for the risk of developing cardiovascular disease.
This reagent is intended to be used by trained personnel in a professional setting and is not intended for home use.
KO13152
Respectfully,
Wynn Stocking
Wynn Stocking Regulatory Affairs Manager Elan Diagnostics
19 September, 2001
Rull chole for Jam coop
(Divisi-Off)
Divinonomnical Laboratory
510(k) Number K013152
(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) X
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)