(22 days)
Calibrators: The ARCHITECT ® DHEA-S Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of DHEA-S in human serum and plasma.
Controls: ARCHITECT® DHEA-S Controls are for the verification of the accuracy and precision of the ARCHITECT i System when used for the quantitative determination of DHEA-S in human serum and plasma.
For in vitro diagnostic use.
Calibrators: The ARCHITECT ® DHEA-S Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of DHEA-S in human serum and plasma.
Controls: The ARCHITECT ® DHEA-S Controls are for the verification of the accuracy and precision of the ARCHITECT i System when used for the quantitative determination of DHEA -S in human serum and plasma.
The provided document, K060027, is a 510(k) summary for the ARCHITECT® DHEA-S Calibrators and Controls. It describes the devices and claims substantial equivalence to a legally marketed predicate device (DPC IMMULITE® DHEA-SO4). However, it does not contain the acceptance criteria or a study demonstrating that the device meets specific performance criteria.
Instead, the submission focuses on comparing the new device's technological characteristics (intended use, methodology, assay protocols, matrix) to the predicate device to demonstrate substantial equivalence. It also lists differences such as the platform, traceability, standardization, calibration range/levels, and value assignment.
The FDA's response confirms that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. This type of submission relies on demonstrating similarity to an already approved device rather than presenting new clinical performance data against specific acceptance criteria.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria based on the provided text. The document does not include such information.
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ARCHITECT ® DHEA-S 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordancewith the requirements of CFR
Preparation date: December 23 rd, 2005
Submitter Contact information:
Mr. Joan Guixer Director of Quality Assurance and Regulatory Affairs Biokit S.A. Llica d'Amunt Barcelona, Spain 08186
Device Name:
Calibrators Classification Name: Calibrator, Secondary Trade Name: ARCHITECT ® DHEA -S Calibrators (A-F) Common name: Calibrator Device Classification: 21 CFR 862.1150 Device Class: Class II Classification Panel: Clinical Chemistry Product Code: JIT
Controls
Classification Name: Single (specified) analyte controls (assayed and unassayed) Trade Name: ARCHITECT ® DHEA -S Controls (Low, Medium, and High) Common name: Control Device Classification: 21 CFR 862.1660 Device Class: Class I Classification Panel: Clinical Chemistry Product Code: JJX
Legally marketed device to which equivalency is claimed:
DPC IMMULITE ® DHEA -SO4
Description of the Device:
Calibrators
The ARCHITECT ® DHEA-S Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of DHEA-S in human serum and plasma.
Controls
The ARCHITECT ® DHEA-S Controls are for the verification of the accuracy and precision of the ARCHITECT i System when used for the quantitative determination of DHEA -S in human serum and plasma.
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Comparison of Technological Characteristics:
Calibrators
Similarities
| Similarities: | ||
|---|---|---|
| Calibrator | Device | Predicate |
| Intended Use | The ARCHITECT® DHEA-SCalibrators are for the calibrationof the ARCHITECT i Systemwhen used for the quantitativedetermination of DHEA-S inhuman serum and plasma. | DHEA-SO4 For thequantatitive determination ofdehydroepiandrosteronesulfate in serum. |
| System Methodology | Chemiluminescent MicroparticleImmunoassay (CMIA) | Chemiluminescent a solidphase enzyme immunoassay |
| Assay Protocols | Competitive assay | Competitive assay |
| Matrix | DHEA-S (synthetic) in humanserum with preservative.(SodiumAzide) | Lyophilized DHEA-SO4 inhuman serum withpreservative |
Controls
Similarities:
| Controls | Device | Predicate |
|---|---|---|
| Intended Use | The ARCHITECT DHEA-SControls are for theverification of the accuracy andprecision of the ARCHITECT iSystem when used for thequantitative determination ofDHEA-S in human serum andplasma | For the quantitativedetermination ofdehydroepiandrosterone sulfatein serum intended strictly for invitro diagnostic use. |
| Methodology | ChemiluminescentMicroparticle Immunoassay(CMIA) | Chemiluminescence a solidphase enzyme immunoassay |
| Assay Protocol | Competitive assay | Competitive assay |
| Matrix | DHEA-S (synthetic) in humanserum with preservative.(SodiumAzide) | Lyophilized DHEA-SO4 inhuman serum with preservative |
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Calibrators
| Differences: | ||
|---|---|---|
| Calibrators | Device | Predicate |
| Platform | ARCHITECT i System | Immulite 2000 Analyzer |
| Traceability | Sigma | Not in package insert |
| Standardization | Value assigned based on mass basisfrom a DHEA-S preparation (100%pure). | Not in package insert |
| Calibration Range/Levels | 0, 5, 12, 60, 300, and 1500 µg/dL | 15-1,000 µg/dL |
Controls 1.66
| Differences | ||
|---|---|---|
| Control | Device | Predicate |
| Platform | ARCHITECT i System | Immulite 2000 Analyzer |
| Matrix | Single constituent, DHEA-S (synthetic)in human serum with preservative.(Sodium Azide) | Multi constituent, Humanserum based tri-level controlcontaining over 25constituents commonlymeasured by immunoassay. |
| Traceability | Sigma | Not in package insert |
| Value Assignment | Relative Light Units matched tosecondary controls | Values derived fromextensive analysis performedby DPC, and reflectinstrument, reagent, and otherwithin laboratory sources ofvariation. |
| Levels | 10, 100, and 1000 µg/dL | Three levels,2SD range70-102,222-288,481-725 µg/dL[Example lot 020] |
| Assay Sample Type | Serum and plasma | Serum |
Conclusion:
As summarized above the ARCHITECT® DHEA-S Calibrators (A-F) and Controls (Low, Medium, and High) are substantially equivalent to the DPC IMMULITE® DHEA-SO4 Colibrators and Controls. Substantial equivalence for the calibrators has been demonstrated as recommended by the FDA guidance for Industry "Abbreviated 510(k) Submission for In Vitro Calibroom" (Issued on: Feb 22, 1999) and for controls as recommended by the FDA Guidance for Industry "Points to Consider Document on Assayed and Unassayed Quality Control Material" (Draft Guidance released for comment on Febuary 3, 1999).
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle faces right and is positioned in the center of the image. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 2 6 2006
Joan Guixer Director, Quality Assurance and Regulatory Affairs BioKit S.A. Llissa D`Amunt Barcelona, Spain 08186
Re: K060027
Trade/Device Name: ARCHITECT® DHEA-S CALIBRATORS (A-F) and ARCHITECT® DHEA-S CONTROLS (LOW, MEDIUM, HIGH) Regulation Number: 21 CFR§862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class II Product Code: JJX, JIT Dated: December 27, 2005 Received: January 4, 2006
Dear Ms. Guixer:
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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Page 2 -
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 (240) 276-0484. 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/industry/support/index.html.
Sincerely yours,
Alberto G
Alberto Gutierrez, Ph.D. 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 Statement
510(k) Number (if known): K060027
Device Name: ARCHITECT® DHEA-S CALIBRATORS (A-F) and ARCHITECT ® DHEA-S CONTROLS (LOW, MEDIUM, HIGH)
Indications for Use:
Calibrators
The ARCHITECT ® DHEA-S Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of DHEA-S in human serum and plasma.
Controls
ARCHITECT® DHEA-S Controls are for the verification of the accuracy and precision of the ARCHITECT i System when used for the quantitative determination of DHEA-S in human serum and plasma.
For in vitro diagnostic use.
Prescription Use × OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (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)
Ann Chappele
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
11 . . KO60027 ...............................................................................................................................................................
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.