(60 days)
Not Found
No
The document describes calibrators and controls for a laboratory system, not the system itself, and there is no mention of AI/ML in the provided text.
No
This device is for the calibration and verification of a system that measures human insulin, not for therapeutic intervention. It is an in-vitro diagnostic (IVD) product that helps ensure the accuracy of a diagnostic test.
No
The device consists of calibrators and controls for an existing system, used for calibrating and verifying the accuracy and precision of quantitative determination of human insulin. These are components used in a diagnostic process, but they are not the diagnostic device itself which performs the determination. They are used to ensure the proper functioning of the diagnostic device.
No
The device description refers to "Calibrators" and "Controls," which are typically physical reagents or materials used in laboratory testing, not software. The intended use also specifies calibration and verification of a physical system ("ARCHITECT® i System").
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the calibrators and controls are for the "quantitative determination of human insulin in human serum and plasma." This involves testing biological samples (serum and plasma) outside of the body to obtain diagnostic information.
- Device Description: The description reiterates the use of the calibrators and controls for the "quantitative determination of human insulin in human serum and plasma" and for "verification of the accuracy and precision" of the system used for this determination. This further confirms its role in an in vitro diagnostic process.
- Predicate Devices: The listed predicate devices (ADIVA Centaur and ACS: 180 Insulin Calibrators; Bayer Ligand Plus 1, 2, 3 Controls) are also IVD devices used in clinical laboratories for similar purposes (insulin testing and quality control).
The core function of these calibrators and controls is to support the accurate and reliable performance of an in vitro diagnostic test (the quantitative determination of insulin in biological fluids). This directly aligns with the definition of an IVD.
N/A
Intended Use / Indications for Use
The ARCHITECT® Insulin Calibrators are for the calibration of the ARCHTECT® i System when used for the quantitative determination of human insulin in human serum and plasma.
The ARCHITECT® Insulin Controls are for the verification of the accuracy and precision of the ARCHITECT® i System when used for the quantitative determination of human insulin in human serum or plasma.
Product codes
JIT, JJX
Device Description
Calibrators
The ARCHITECT® Insulin Calibrators are for the calibration of the ARCHITECT® i System when used for the quantitative determination of human insulin in human serum and plasma.
Controls
The ARCHITECT® Insulin Controls are for the verification of the accuracy and precision of the ARCHITECT® i System when used for the quantitative determination of human insulin in human serum and plasma.
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
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special 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.
0
APR 1 4 2006
This is a Summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of CFR.
The assigned 510(k) Number is: Company/Contact Person Hideo G. Noda Denka Seiken Co., Ltd. 3-4-2 Nihonbashi Kayabacho, Chuo-ku, Tokyo, Japan 103-0025 Operator Number: 9053049 Establishment Registration Number: 3003871639 Date Prepared: Dec 19, 2005
Device Name
Calibrators
Trade Name: ARCHITECT® Insulin Calibrators (A-F) Common Name: Calibrator Device Classification: 21 CFR 862:1150 Class II Classification Panel: Clinical Chemistry Product Code: JIT
Controls
Trade Name: ARCHITECT® Insulin Controls (Low, Medium, and High) Common name: Quality Control Material (Assayed) Single (Specified) analyte Device Classification: 1 CFR 862:1660 Class I Classification Panel: Clinical Chemistry Product Code: JJX
Legally marketed device to which equivalency is claimed: ADIVA Centaure and ACS: 180 Insulin
1
Indications for Use
Koco359 510(k) Number (if known) All
Device Name: ARCHITECT® Insulin Calibrators and Controls
Indications For Use:
Intended Use and Indications for use
The ARCHITECT® Insulin Calibrators are for the calibration of the ARCHTECT® i System when used for the quantitative determination of human insulin in human serum and plasma.
The ARCHITECT® Insulin Controls are for the verification of the accuracy and precision of the ARCHITECT® i System when used for the quantitative determination of human insulin in human serum or plasma.
______________________________________________________________________________________________________________________________________________________________________________ Prescription Use YES (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use NO (21 CFR 801 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)
2
Description of the Device
Calibrators
The ARCHITECT® Insulin Calibrators are for the calibration of the ARCHITECT® i System when used for the quantitative determination of human insulin in human serum and plasma.
Controls
The ARCHITECT® Insulin Controls are for the verification of the accuracy and precision of the ARCHITECT® i System when used for the quantitative determination of human insulin in human serum and plasma.
Comparison of Technological Characteristics:
The ARCHITECT® Insulin Calibrators (A-F) is substantially equivalent to the ADIVA Centaur and ACS 180 Insulin Calibrators (K021535).
Comparison with predicate: Calibrators
Similarities:
| Calibrator | Device | Predicate |
|---|---|---|
| Intended Use | The ARCHITECT® Insulin | |
| calibrators are for | ||
| calibration of the | ||
| ARCHITECT® i System | ||
| when used for the | ||
| quantitative determination of | ||
| human insulin in human | ||
| serum and plasma. | For in vitro diagnostic use in | |
| the calibrating the ADIVA | ||
| Centaur® or ACS 180® | ||
| Insulin assays. | ||
| Methodology | CMIA (Chemiluminescent | |
| Microparticle Immunoassay) | Chemiluminescent | |
| Microparticle Immunoassay | ||
| Binding Protein | Insulin | Insulin |
| Assay Protocols | Direct, quantitative | |
| immunoassay | Direct, quantitative | |
| immunoassay | ||
| Traceability | ||
| /Standardization | Relative Light Unit (RLU) | |
| matched to Primary | ||
| Calibrators. The | ||
| calibrators of the | ||
| ARCHITECT Insulin are | ||
| referenced to the World | ||
| Health Organization (WHO) | Referenced to the World | |
| Health Organization (WHO) | ||
| Insulin 1st. International | ||
| Reference Preparation, | ||
| 66/304. | ||
| Assigned values of |
3
| Insulin 1st. International
Reference Preparation,
66/304 | calibrators are traceable to
this standardization |
| ---------------------------------------------------------------- | ------------------------------------------------------ |
|---|
Comparison with predicate: Controls
The ARCHITECT® Insulin Controls (Low, Medium and High) are substantially equivalent to the Bayer Ligand Plus 1, 2, 3 Controls (K030452).
Comparison with predicate: Controls
Similarities:
| Controls | Device | Predicate |
|---|---|---|
| Intended Use | The ARCHITECT® Insulin | |
| Controls are for the | ||
| verification of the accuracy | ||
| and precision of the | ||
| ARCHITECT® i System | ||
| when used for the | ||
| quantitative determination of | ||
| human insulin in human | ||
| serum and plasma. | For the in vitro diagnostic | |
| use to monitor the precision | ||
| and accuracy of | ||
| immunochemistry and | ||
| procedures for ADIVA | ||
| Centaur® and ACS 180® | ||
| Systems. | ||
| Methodology | Chemiluminescent | |
| Microparticle Immunoassay | ||
| (CMIA) | Chemiluminescent | |
| Microparticle Immunoassay | ||
| Binding Protein | Insulin | Insulin |
| Assay Protocol | Direct, quantitative | |
| immunoassay | Direct, quantitative | |
| immunoassay | ||
| Levels | 3 levels Low, Medium and | |
| High: targets: 8, 40, | ||
| 120 μU/mL. | 3 levels (Ligand 1, 2, 3). |
Comparison with predicate: Calibrators
Differences:
| Calibrators | Device | Predicate |
|---|---|---|
| Platform | ARCHITECT® i System | ADIVA Centaur® or ACS |
| 180® | ||
| Matrix | Acetate buffer with sodium | Buffered saline with |
4
| | azide and preservatives | casein, potassium
thiocyanate (3.89%),
sodium azide and
preservatives |
|--------------------------|------------------------------------------------|--------------------------------------------------------------------------------|
| Calibration Range/Levels | 6 levels: 0, 3, 10, 30, 100,
and 300 µU/mL, | High and Low level, per
assigned value card |
| Assay Sample Type | Serum and plasma | Serum |
Comparison with predicate: Controls
Differences:
| Control | Device | Predicate |
|---|---|---|
| Platform | ARCHITECT® i System | ADIVA Centaur® or ACS |
| 180° | ||
| Matrix | Acetate buffer with | |
| preservatives | Lypholized, Multi | |
| Constituent Controls. | ||
| Human serum with | ||
| nonhuman contents added, | ||
| no preservatives or | ||
| stabilizers | ||
| Traceability | Primary Controls | Not given |
| Value Assignment | Relative Light Unit (RLU) | |
| matched to Primary | ||
| Controls. | Adjusted to the level listed | |
| in expected values of assay | ||
| package insert. | ||
| Assay Sample Type | Serum and plasma | Serum |
Conclusion:
As summarized above the ARCHITECT® Insulin Calibrators (A-F) and Controls (Low, Medium, and High) are substantially equivalent to the ADIVA Centaur® and ACS: 180® Insulin Calibrators (K021535) and Bayer Ligand Plus 1, 2, 3 Controls (K030452).
Substantial equivalence for the calibrators has been demonstrated as recommended by the FDA Guidance for Industry "Abbreviated 510(k) Submission for In Vitro Calibrators" (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 February 3, 1999).
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its wings. The eagle is positioned to the right of the department's name, which is written in a circular pattern around the logo. The text is in all capital letters and is written in a sans-serif font.
Public Health Service
Food and Druq Administration 2098 Gaither Road Rockville MD 20850
APR 1 4 2006
Mr. Toshimi Matsunaga Denka Seiken Co., Ltd. 1-2-2 Minamihoncho, Gosen-shi Niigata, Japan 959-1695
Re: K060359
Trade/Device Name: ARCHITECT® Insulin Calibrators and Controls Regulation Number: 21 CFR§862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT, JJX Dated: February 2, 2006 Received: March 2, 2006
Dear Mr. Matsunaga:
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).
6
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,
Albert G. A.
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
7
Indications for Use
510(k) Number (if known) NA K060359
Device Name: ARCHITECT® Insulin Calibrators and Controls
Indications For Use:
Intended Use and Indications for use
The ARCHITECT® Insulin Calibrators are for the calibration of the ARCHTECT® i System when used for the quantitative determination of human insulin in human serum and plasma.
The ARCHITECT® Insulin Controls are for the verification of the accuracy and precision of the ARCHITECT® i System when used for the quantitative determination of human insulin in human serum or plasma.
| Prescription Use
| (Part 21 CFR 801 Subpart D) | YES |
|---|---|
| AND/OR | |
| Over-The-Counter Use | |
| (21 CFR 801 Subpart C) | NO |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Office of In Vitro Diagnostic Device
Evaluation and Safety