(57 days)
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No
The description details a standard immunoassay system and its components, with no mention of AI or ML technologies. The performance studies focus on analytical metrics typical of such assays.
No
The device is used for diagnostic purposes by measuring DHEA-S levels, not for treating a condition.
Yes
The 'Intended Use / Indications for Use' section explicitly states that "Measurement of dehydroepiandrosterone sulfate may be used in the differential diagnosis of Cushing's syndrome as well as in the evaluation of adrenocortical diseases, congenital adrenal hyperplasia, and adrenal tumors." This directly indicates the device's diagnostic purpose.
No
The device description clearly indicates it is a reagent and calibrators intended for use with specific immunoassay systems, which are hardware devices. It is not a standalone software product.
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 assay is for the "quantitative measurement of dehydroepiandrosterone sulfate levels in human serum and plasma." This is a measurement performed in vitro (outside the body) on biological samples.
- Diagnostic Purpose: The intended use also describes how the measurement of DHEA-S levels "may be used in the differential diagnosis of Cushing's syndrome as well as in the evaluation of adrenocortical diseases, congenital adrenal hyperplasia, and adrenal tumors." This clearly indicates a diagnostic purpose – providing information to aid in the diagnosis or evaluation of medical conditions.
- Sample Type: The assay is performed on "human serum and plasma," which are biological specimens.
- Device Description: The description details a "chemiluminescent immunoassay" and "reagent packs" and "calibrators" used on "Immunoassay Systems." These are all components and methods typical of in vitro diagnostic devices.
The information provided aligns perfectly with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
The Access DHEA-S assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative measurement of dehydroepiandrosterone sulfate levels in human serum and plasma using the Access Immunoassay Systems.
Measurement of dehydroepiandrosterone sulfate may be used in the differential diagnosis of polycystic ovary syndrome, as well as in the evaluation of adrenocortical diseases, congenital adrenal hyperplasia, and adrenal tumors. In hirsute female patients, increased DHEA-S levels have been associated with virilizing adrenal tumors. Patients with polycystic ovary syndrome have often demonstrated elevated levels of DHEA-S, emphasizing its overall androgen contribution to the defect in this disorder.
The Access DHEA-S Calibrators are intended to calibrate the Access DHEA-S assay for the quantitative determination of Dehydroepiandrosterone sulfate levels in human serum and plasma using the Access Immunoassay Systems.
Product codes (comma separated list FDA assigned to the subject device)
JIT, JKC
Device Description
The Access® DHEA-S Reagent is designed for optimal performance on the Access family of Immunoassay Systems, including the Access and Access 2, UniCel DxI and UniCel DxC 600i, and SYNCHRON LX® 725 Clinical Analyzer Systems. The Access Immunoassay Systems utilize chemiluminescent technology for quantitative analyte measurement. The Access DHEA-S Reagent is supplied in two 50-test reagent packs and is packaged separately from the associated calibrators. The Access DHEA-S Calibrators are designed for use with the Access DHEA-S Reagent for generation of the Access calibration curve on Access Immunoassay Systems. The Access Calibrators are supplied in 2.0 mL bottles, one for each of six calibrator levels.
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
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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 data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Assay equivalence is demonstrated through method comparison, linearity, and imprecision experiments.
Method comparison:
Candidate Method: Access DHEA-S Assay
Slope: 1.028
Intercept: 6.6
r: 0.993
n: 263
Predicate Method: Immulite DHEA-SO4 Assay
Estimated Imprecision:
Within-Run Imprecision (N=80 for each level):
Level 1: Mean 10.3 ug/dL, SD 0.86 ug/dL, %C.V. 8.3
Level 2: Mean 34.4 ug/dL, SD 1.10 ug/dL, %C.V. 3.2
Level 3: Mean 123.9 ug/dL, SD 5.90 ug/dL, %C.V. 4.8
Level 4: Mean 347.3 ug/dL, SD 8.92 ug/dL, %C.V. 2.6
Level 5: Mean 736.1 ug/dL, SD 12.10 ug/dL, %C.V. 1.6
Total Imprecision (N=80 for each level):
Level 1: Mean 10.3 ug/dL, SD 1.16 ug/dL, %C.V. 11.3
Level 2: Mean 34.4 ug/dL, SD 1.76 ug/dL, %C.V. 5.1
Level 3: Mean 123.9 ug/dL, SD 7.99 ug/dL, %C.V. 6.4
Level 4: Mean 347.3 ug/dL, SD 15.40 ug/dL, %C.V. 4.4
Level 5: Mean 736.1 ug/dL, SD 27.20 ug/dL, %C.V. 3.7
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.
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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§ 862.1245 Dehydroepiandrosterone (free and sulfate) test system.
(a)
Identification. A dehydroepiandrosterone (free and sulfate) test system is a device intended to measure dehydroepiandrosterone (DHEA) and its sulfate in urine, serum, plasma, and amniotic fluid. Dehydroepiandrosterone measurements are used in the diagnosis and treatment of DHEA-secreting adrenal carcinomas.(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
KO40181
510(k) Summary
Submitted By: 1.0
Mary Beth Tang Staff Regulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd. W-104 Brea, CA 92822-8000 Telephone: (714) 961-3777 FAX: (714) 961-4123
Date Submitted 2.0
January 26, 2004
Device Name(s): 3.0
Proprietary Names 3.1 Access® DHEA-S Reagent Access® DHEA-S Calibrators
Classification Names 3.2 3.2 Calibrator (21 CFR § 862.1150)
Legally Marketed Device 4.0
| Candidate(s) | Predicate | Manufacturer | Docket
Number |
|------------------------------|------------------------------------------|--------------------------------|------------------|
| Access DHEA-S Reagent | Immulite DHEA-SO4
Reagent | Diagnostic Products,
Corp.* | K935806 |
| Access DHEA-S
Calibrators | Access Ultrasensitive hGH
Calibrators | Beckman Coulter, Inc. | K003098 |
*Diagnostic Products, Corp., Los Angeles, CA
** Beckman Coulter, Inc., Chaska, MN
Device Description 5.0
The Access® DHEA-S Reagent is designed for optimal performance on the Access family of The Access® DriEA-S Reagent is dosigned or op. Access 2, Unicel Parties Comments Createms utilize a ന്നീധിരക്ടാം Systems, Indusing The Access Immunoassay Systems utilize and SYNCHRON EX® T25 Gilnoar andiyEstor the for quantitative analyte measurement. compellive biriding inimalloonizments two 50-test reagent packs and is packaged The Access DHEA-S Calibrators are separately from the associated calibrators. separately "Iron" the "disociation" call:a.ler" of the DHEA-S Reagent for generation of the Access designed for use with the Access Britiz's Access Immunoassay Systems. The Access callbration curve 'or 'Bookman' '60 mL bottles, one for each of six calibrator levels.
Intended Use 6.0
The Access DHEA-S assay is a paramagnetic particle, chemiluminescent inhumor The Access DrilLA-0 assay is a paramaghotic parantosterone sulfate levels in human serum and plasma using the Access Immunoassay Systems. The Access DHEA-S Selum and prasma using the Access DHEA-S assay for the quantitative Calibrators are intended to oalbrate the Research in human serum and plasma using the Access Immunoassay Systems.
1
Comparison to the Predicate 7.0
The following table shows similarities and differences between the predicates identified in Section 4.0 of this summary:
| Access DHEA-S
| Reagent | Similarities | |
|---|---|---|
| Intended Use | Same as Diagnostic Products | |
| Methodology | Immulite DHEA-SO4 Reagent | |
| Antibody source (rabbit) | ||
| Chemiluminescent substrate | ||
| Liquid-stable reagents | ||
| Differences | ||
| Sample Type | DHEA-S: Serum, Plasma | |
| DHEA-SO4: Serum | ||
| Sample Volume | DHEA-S: 10 µL | |
| DHEA-SO4: 5 µL | ||
| Reportable Range | DHEA-S: 2 - 1000 µg/dL | |
| DHEA-SO4: 15-1000 µg/dL | ||
| Analytical Sensitivity | DHEA-S: 2 µg/dL | |
| DHEA-SO4: 3 µg/dL | ||
| Calibrator Matrix | DHEA-S: Liquid-stable | |
| DHEA-SO4: Lyophillized | ||
| Calibration Scheme | DHEA-S: 6-point curve | |
| DHEA-SO4: 2-point adjustment |
The Access DHEA-S Calibrators and the predicate calibrator utilize the same test methodology specific to Access Immunoassay Systems. Each calibrator is intended for use in a different analyte test system. Both calibrators are derived from a stabilized bovine serum albumin preparation. The Access DHEA-S Calibrators are liquid stable while the predicate calibrator is lyophilized and requires preparation.
8.0 Summary of Performance Data
The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Assay equivalence is demonstrated through method comparison, linearity, and imprecision experiments.
| Access DHEA-S Method Comparison Study Results | |||||
|---|---|---|---|---|---|
| Candidate Method | Slope | Intercept | r | n | Predicate Method |
| Access DHEA-S Assay | 1.028 | 6.6 | 0.993 | 263 | Immulite DHEA-SO4 Assay |
| Sample | Mean (µg/dL) | S.D. (µg/dL) | %C.V. | N |
|---|---|---|---|---|
| Within-Run Imprecision | ||||
| Level 1 | 10.3 | 0.86 | 8.3 | 80 |
| Level 2 | 34.4 | 1.10 | 3.2 | 80 |
| Level 3 | 123.9 | 5.90 | 4.8 | 80 |
| Level 4 | 347.3 | 8.92 | 2.6 | 80 |
| Level 5 | 736.1 | 12.10 | 1.6 | 80 |
| Total Imprecision | ||||
| Level 1 | 10.3 | 1.16 | 11.3 | 80 |
| Level 2 | 34.4 | 1.76 | 5.1 | 80 |
| Level 3 | 123.9 | 7.99 | 6.4 | 80 |
| Level 4 | 347.3 | 15.40 | 4.4 | 80 |
| Level 5 | 736.1 | 27.20 | 3.7 | 80 |
Access DHEA-S Estimated Imprecision
This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three human figures.
MAR 2 4 2004
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Mary Beth Tang Staff Regulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kaemer Blvd., W-104 P.O. Box 8000 Brea, California 92822-8000
Re: K040181
Trade/Device Name: Access® DHEA-S Reagent and Calibrators Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT: JKC Dated: January 26, 2004 Received: January 27, 2004
Dear Ms. Tang:
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,
Jean M. Cooper, MS, DVM.
Yean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K040181
Device Name: Access® DHEA-S Reagent and Calibrators
Indications For Use:
The Access DHEA-S assay is a paramagnetic particle, chemiluminescent immunoassay The Access DFIEA O doody is a para. Regiveroepiandrosterone sulfate levels in human serum and plasma using the Access Immunoassay Systems.
Measurement of dehydroepiandrosterone sulfate may be used in the differential Measurement of "donyarooplanars well as in the evaluation of adrenocortical diseases, diagnosis of Ouoning o cynaremer as ia and adrenal tumors. In hirsute female patients, increased DHEA-S levels have been associated with virilizing adrenal tumors. PHEA with polycystic ovary syndrome have often demonstrated elevated levels of DHEA-S, with persons overal androgen contribution to the defect in this disorder.
The Access DHEA-S Calibrators are intended to calibrate the Access DHEA-S assay The Accoss Drill F O commination of Dehydroepiandrosterone sulfate levels in human serum and plasma using the Access Immunoassay Systems.
Prescription Use
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Albert C. G.
Page 1 of
Division Sign-Qff
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K040181