(14 days)
For determination of the instrument specific Direct Amylase reagent factor for analyzers using Genzyme Direct Amylase Reagent.
The Genzyme Direct Amylase Verifier is intended to be used as a companion product with the Genzyme Direct Amylase reagent manufactured by Genzyme but sold separately. The product is buffer formulated with human amylase and preservative. The Verifier values are in the clinically relevant range of 200 U/L to 275 U/L. The Direct Amylase Verifier is for use during initiation or validation of Genzyme Direct Amylase reagent on a clinical chemistry analyzer to confirm the analyzer has the correct enzyme factor. It is possible this Verifier would need to be used again if significant maintenance was performed on the analyzer and this is addressed in the Direct Amylase Verifier product labeling.
Here's a breakdown of the acceptance criteria and study information for the Genzyme Direct Amylase Verifier, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Substantial equivalence to the legally marketed predicate device: The Genzyme Direct Amylase Reagent on the Roche Cobas FARA Analyzer. | The Genzyme Direct Amylase Verifier used with the Genzyme Direct Amylase reagent on other analyzers performs substantially equivalent to the Genzyme Direct Amylase Reagent on the Roche Cobas FARA Analyzer. |
| The device should serve as a calibrator for the Genzyme Direct Amylase assay. | The Genzyme Direct Amylase Verifier is intended to be used as a companion product with the Genzyme Direct Amylase reagent... for use during initiation or validation of Genzyme Direct Amylase reagent on a clinical chemistry analyzer to confirm the analyzer has the correct enzyme factor. |
| The Verifier values should be in a clinically relevant range. | The Verifier values are in the clinically relevant range of 200 U/L to 275 U/L. |
| The device should be able to confirm the correct enzyme factor on a clinical chemistry analyzer when used with the Genzyme Direct Amylase reagent. | It is for use during initiation or validation of Genzyme Direct Amylase reagent on a clinical chemistry analyzer to confirm the analyzer has the correct enzyme factor. |
Study Information:
- Study Description: The provided text mentions "results obtained in Genzyme's testing" to demonstrate substantial equivalence. However, it does not provide details about the specific study design, methodology, or results beyond the general statement of equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided text.
- Data Provenance: The text states "results obtained in Genzyme's testing," implying that the data was generated internally by Genzyme. There is no information regarding the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided as the device is a calibrator for a diagnostic assay, and its performance is typically evaluated against analytical standards or a predicate device's measured values, rather than human expert interpretation of a diagnostic output.
4. Adjudication Method for the Test Set
- This information is not applicable/not provided as the device is a calibrator and does not involve human interpretation or adjudication for its performance evaluation in the context described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices that involve human interpretation of images or other complex outputs to assess the impact of AI assistance on human reader performance. The Genzyme Direct Amylase Verifier is a calibrator for a biochemical assay and does not involve such a process.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, in essence, a standalone performance was done for the calibrator. The "Genzyme's testing" that demonstrated substantial equivalence would have evaluated the calibrator's performance analytically in its intended use, which is an "algorithm only" type of evaluation in this context (i.e., the calibrator's ability to produce correct values on an analyzer independently of human interpretation).
7. The Type of Ground Truth Used
- The ground truth in this context would likely be established analytical values or a reference standard for amylase activity, against which measurements obtained using the Genzyme Direct Amylase Verifier are compared. The text mentions it is a "buffer formulated with human amylase," suggesting a known concentration of amylase. The comparison is made to the performance of the "Genzyme Direct Amylase Reagent on the Roche Cobas FARA Analyzer," which serves as the predicate device and thus its performance acts as a reference.
8. The Sample Size for the Training Set
- This information is not applicable/not provided. The Genzyme Direct Amylase Verifier is a physical calibrator product, not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable/not provided as the device is not an AI/ML algorithm that uses a training set.
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4 1999
510(k) PREMARKET NOTIFICATION
1993132
Genzyme Corporation One Kendall Square Cambridge, MA 02139 Genzyme Direct Amylase Verifier
September 15, 1999
510(k) Summary Of Safety and Effectiveness Information Upon Which An Equivalence Determination Could be Made
| Trade or Proprietary Name: | Genzyme Direct Amylase Verifier |
|---|---|
| Common or Usual Name: | Calibrator for the Genzyme Direct Amylase assay |
| Classification Name: | Calibrator, Secondary |
| Manufacturer: | Genzyme DiagnosticsOne Kendall SquareCambridge, MA 02139-1562 |
Contact Person: Robert Yocher, Vice President, Regulatory Affairs (617) 374-7275 Barbara Pizza, Manager, Regulatory Affairs (617) 252-7953
The Genzyme Direct Amylase Verifier is intended to be used as a companion product with the Genzyme Direct Amylase reagent manufactured by Genzyme but sold separately. The product is buffer formulated with human amylase and preservative. The Verifier values are in the clinically relevant range of 200 U/L to 275 U/L. The Direct Amylase Verifier is for use during initiation or validation of Genzyme Direct Amylase reagent on a clinical chemistry analyzer to confirm the analyzer has the correct enzyme factor. It is possible this Verifier would need to be used again if significant maintenance was performed on the analyzer and this is addressed in the Direct Amylase Verifier product labeling.
The Genzyme Direct Amylase Verifier used with the Genzyme Direct Amylase reagent on other analyzers performs substantially equivalent to the Genzyme Direct Amylase Reagent on the Roche Cobas FARA Analyzer as demonstrated by results obtained in Genzyme's testing.
In lieu of a 510(k) statement under 513(i) of the Act, this information is provided as a 510(k) summary for disclosure to any other persons/companies without the specific written authorization from Genzyme Corporation.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol representing the human form, with three stylized profiles facing to the right, suggesting a sense of community and support.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
4 1999 OCT
Ms. Barbara Pizza Manager. Regulatory Affairs Genzyme Corporation One Kendall Square Cambridge, Massachusetts 02139-1562
K993132 Trade Name: Genzyme Direct Amylase Verifier Regulatory Class: II Product Code: JIT Dated: September 15, 1999 Received: September 20, 1999
Dear Ms. Pizza:
Re:
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 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). 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 (Premarket Approval), 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 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 regulation may result in regulatory 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 obligation 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.
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Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
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 diagnostic 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/cdrl/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
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
. . . . . . . . . . . . . . . . .
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t Amylase Verifier
| Genzyme Corporation | Direct |
|---|---|
| One Kendall Square | |
| Cambridge, MA 02139 | CONFIDENTIAL |
ptember 15, 1999
3.0 INTENDED USE
Page __ 1_ of __ 1
510(k) Number (if known): K993132
Device Name: __ Direct Amylase Verifier
Indications for Use:
For determination of the instrument specific Direct Amylase reagent factor for analyzers using Genzyme Direct Amylase Reagent.
Sean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devicu.
510(k) Number K 993132
(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)
OR
Over-The-Counter-Use (Optional Format 1-2-96)
§ 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.