(12 days)
Not Found
No
The document describes a verification test set for a laboratory assay, not a device that processes data or images using AI/ML.
No
The device is described as a 'MasterCheck' intended for the verification of sensitivity, calibration linearity, and reportable range of a Prolactin assay on an Abbott Architect i System. This indicates it is a quality control or calibrator product for an in-vitro diagnostic test, not a device used to treat a condition.
No
This device is a "MasterCheck" intended for the verification of an assay's performance on a diagnostic system, not for diagnosing a patient's condition itself. It's a quality control material rather than a diagnostic tool.
No
The device description clearly states that the device contains physical components (HEPES buffer, protein stabilizers, prolactin, antimicrobial agent) and is intended for use with a specific hardware system (Abbott Architect i System). It is a reagent/control material, not software.
Based on the provided information, the Architect Prolactin MasterCheck is likely an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states it's for "verification of sensitivity, calibration linearity, and reportable range of the Prolactin assay on the Abbott Architect i System." This indicates it's used in vitro (outside the body) to assess the performance of a diagnostic test (the Prolactin assay).
- Device Description: The description details the composition of the product, which are solutions containing biological components (prolactin, protein stabilizers) and buffer. These are typical components of reagents or calibrators used in laboratory testing.
- Predicate Device: The mention of a predicate device (K950469 Casco Standards Document Serum Multi-Analyte Verification Test Set) strongly suggests that this device is being compared to a previously cleared IVD device with a similar function. This is a common practice in the regulatory pathway for IVDs.
While the document doesn't explicitly state "This is an IVD device," the combination of its intended use, composition, and the reference to a predicate IVD device points towards it being classified as an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Architect Prolactin MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the Prolactin assay on the Abbott Architect i System.
Product codes (comma separated list FDA assigned to the subject device)
JJX
Device Description
Architect Prolactin MasterCheck Level 0 contains HEPES buffer with protein (bovine) stabilizers.
Architect Prolactin MasterCheck Levels 1, 2, 3 and 4 contain prolactin (human) prepared in HEPES buffer with protein (bovine) stabilizers.
Preservative: Antimicrobial Agent.
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): 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.
Not Found
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).
Not Found
§ 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.
0
DEC 1 5 1998
Image /page/0/Picture/1 description: The image shows the logo for Bio-Rad. The text "BIO-RAD" is written in bold, white letters against a black background. The logo has a rounded, rectangular shape.
Bio-Rad Laboratories
Diannostics Group 9500 Jeronimo Road Irvine, California 92618-2017 Telephone: (949) 598-1200
510(k) Summary
Submitter Bio-Rad Laboratories 9500 Jeronimo Road Irvine, CA (949)598-1285 Fax (949)598-1555
Contact Person Elizabeth Platt
Date of Summary Preparation December 02, 1998
Device (Trade & Common Name) Architect Prolactin MasterCheck
Classification Name Class 1, 75JJX CFR 862.1660: Single (Specified) Analyte Controls (Assayed and Unassayed)
Devices to Which Substantial Equivalence is Claimed Document Serum Multi-Analyte Verification Test Set Casco Standards Yarmouth, ME K950469
Statement of Intended Use
Architect Prolactin MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the Prolactin assay on the Abbott Architect i System.
1
Image /page/1/Picture/0 description: The image shows the logo for Bio-Rad Laboratories. The logo is in black and white, with the words "BIO-RAD" in bold, sans-serif font. The letters are white, and the background is black. The logo is enclosed in a rounded rectangle.
Bio-Rad Laboratories
Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017 Telephone: (949) 598-1200
Description of the Device
Architect Prolactin MasterCheck Level 0 contains HEPES buffer with protein (bovine) stabilizers.
Architect Prolactin MasterCheck Levels 1, 2, 3 and 4 contain prolactin (human) prepared in HEPES buffer with protein (bovine) stabilizers.
Preservative: Antimicrobial Agent.
Statement of How Technological Characteristics Compare to Substantial Equivalence Device
A table is provided below comparing the similarities between the Bio-Rad Architect Prolactin MasterCheck and the devices to which substantial equivalence is claimed.
| | Architect Prolactin MasterCheck | Casco Standards Document
Serum Multi-Analyte
Verification Test Set |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use | Verification of sensitivity,
calibration linearity, and
reportable range of the
Prolactin assay on the Abbott
Architect i System. | In vitro diagnostic use in the
quantitative determination of
linearity, calibration
verification and verification
of reportable range using
automated, semi-automated
and manual methods. |
| Form | Liquid | Liquid |
| Matrix | HEPES buffer with protein
(bovine) stabilizers | Human Serum |
| Storage | 2-8°C | -10 to -20°C |
| Analytes | Prolactin | Multiple |
| Open Vial
Claim | 3 Days at 2-8°C. | 30 Days at 2-8°C. |
| Differences | Calibration verifier for the
Architect Prolactin assay. | Calibration verifier for
multiple analytes. |
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized caduceus-like symbol with three intertwined lines resembling a double helix or abstract bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the symbol.
DEC 15 1998
Ms. Elizabeth Platt Requlatory Affairs Supervisor Bio-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017
Re : K984324 Architect Prolactin MasterCheck Trade Name: Regulatory Class: I Product Code: JJX Dated: December 2, 1998 Received: December 3, 1998
Dear Ms. Platt:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to leqally 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). You may, therefore, market the device, subject to the general controls provisions of the Act. The qeneral 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obliqation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
3
Paqe 2
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Steven Putman
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
Page 1 of 1
510(k) Number: _______________________________________________________________________________________________________________________________________________________________
Device Name: Architect Prolactin MasterCheck
Indications for Use:
Architect Prolactin MasterCheck is intended for use in the verification of sensitive and clastin Master Check is intended for use in the verification of
sensitivity, calibration linearity, and reportable range of the Prolactin assay
on the Abbott Ar on the Abbott Architect i System.
(PLEASE DO NOT WRITE BELOW THE LINE-CONTINUE ON ANOTHER PAGE IF
NEEDED)
(Concurrence of CDRH, Office of Device Evaluation)
| (Division Sign-Off) | |
|---|---|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | 984324 |
| Prescription Use | OR | Over-The Counter Use | ||
|---|---|---|---|---|
| ------------------ | ------------- | ---- | ---------------------- | -- |