(59 days)
Not Found
Not Found
No
The summary describes a quantitative chemical assay for measuring enzyme activity, with no mention of AI/ML terms, image processing, or data-driven algorithms for interpretation.
No
The device is an in vitro diagnostic (IVD) reagent used for quantitative determination of α-Amylase activity, primarily for diagnosing acute pancreatitis. It does not provide any treatment or therapy to a patient.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device provides "needed evidence for the diagnosis of acute pancreatitis" and is "For In Vitro Diagnostic Use," indicating its purpose in disease diagnosis.
No
The device description explicitly states it is a "Reagent," which is a chemical substance used in a laboratory test, indicating it is a physical component, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states "For In Vitro Diagnostic Use." It also describes the intended use as the quantitative determination of α-Amylase activity in human serum or plasma, which is a common type of in vitro diagnostic test.
- Device Description: The description confirms it's a "quantitative method for the detection of a-amylase activity in serum and plasma," further supporting its IVD nature.
- Intended User/Care Setting: The intended user is a "clinical laboratory setting," which is where IVD tests are typically performed.
N/A
Intended Use / Indications for Use
The Genzyme Direct Amylase Reagent assay in the clinical laboratory setting is substantially equivalent to a currently marketed method for Roche Boehringer Mannheim α-Amylase/EPS for the diagnosis of Pancreatitis.
For the quantitative determination of α-Amylase activity in human serum or plasma.
Levels of serum and plasma α-amylase in patients have provided needed evidence for the diagnosis of acute pancreatitis.
For In Vitro Diagnostic Use.
Product codes
JFJ
Device Description
The Genzyme Direct Amylase Reagent is a quantitative method for the detection of a-amylase activity in 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
clinical laboratory setting
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)
Comparative Performance Studies: A Comparative performance study was conducted using the Genzyme Direct Amylase Reagent, and predicate method (Roche Boehringer Mannheim x-Amylase/EPS).
Number of samples: 50
Slope: 0.90
Intercept (U/L): -2.50
Correlation Coefficient (r): 0.9985
Sample Range (U/L) (EPS): 28 - 304
Sample Range (U/L) (Genzyme): 22 - 278
Results: The Genzyme method yielded acceptable correlation with the predicate method for samples across the usable range of the product.
Linearity: Linearity studies demonstrated that the Direct Amylase assay is linear up to 2000 U/L.
Precision: Both within-run and between-run studies were performed. Testing was done using frozen serum pools at three target levels of x-amylase activity for within-run precision and between-run.
Within-Run: Each serum pool was tested 20 times in one batch using the Direct Amylase assay. The mean, standard deviation (SD) and coefficient of variation (%CV) were calculated for each serum pool.
Results: The Direct Amylase assay yielded excellent within-run precision with CVs of
§ 862.1070 Amylase test system.
(a)
Identification. An amylase test system is a device intended to measure the activity of the enzyme amylase in serum and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).(b)
Classification. Class II.
0
510(k) PREMARKET NOTIFICATION
Genzyme Corporation One Kendall Square Cambridge, MA 02139 Direct Amylase Reagent
June 11, 2001
AUG 1 0 2001
ATTACHMENT 1
510(k) Summary Of Safety and Effectiveness Information Upon Which An Equivalence Determination Could be Made
| Trade or Proprietary Name: | Genzyme Direct α-Amylase Test Reagent |
|---|---|
| Common or Usual Name: | Reagent for α-Amylase Test |
| Classification Name: | Amylase Test System |
| Establishment Name and Address | Genzyme Corporation |
| One Kendall Square | |
| Cambridge, MA 02139-1562 | |
| Contact Person: | Barbara Pizza, Manager, Regulatory Affairs |
| (617) 252-7953 |
The use of the Genzyme Direct Amylase Reagent assay in the clinical laboratory setting is substantially equivalent to a currently marketed method for Roche Boehringer Mannheim α-Amylase/EPS for the diagnosis of Pancreatitis.
The Genzyme Direct Amylase Reagent is a quantitative method for the detection of a-amylase activity in serum and plasma.
PERFORMANCE STUDIES
Comparative Performance Studies
A Comparative performance study was conducted using the Genzyme Direct Amylase Reagent, and predicate method (Roche Boehringer Mannheim x-Amylase/EPS).
The slope, intercept, correlation coefficient, and sample range for this comparison is provided below.
1
Koi/8743
510(k) PREMARKET NOTIFICATION
Genzyme Corporation One Kendall Square Cambridge, MA 02139 Direct Amylase Reagent
June 11, 2001
| | Direct Amylase vs. Roche
Serum |
|-----------------------------|-----------------------------------|
| Number of samples | 50 |
| Slope | 0.90 |
| Intercept (U/L) | -2.50 |
| Correlation Coefficient (r) | 0.9985 |
| Sample Range (U/L) | 28 - 304 (EPS) |
| Sample Range (U/L) | 22 - 278 (Genzyme) |
The Genzyme method yielded acceptable correlation with the predicate method for samples across the usable range of the product.
Linearity
Linearity studies demonstrated that the Direct Amylase assay is linear up to 2000 U/L.
Precision
Both within-run and between-run studies were performed. Testing was done using frozen serum pools at three target levels of x-amylase activity for within-run precision and between-run.
Within-Run
Each serum pool was tested 20 times in one batch using the Direct Amylase assay. The mean, standard deviation (SD) and coefficient of variation (%CV) were calculated for each serum pool.
| --------
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The Direct Amylase assay yielded excellent within-run precision with CVs of ≤ 2.0%.
Between-Run
Each serum pool was tested in duplicate, twice per day, for at least five days using the Direct Amylase assay for a total of 40 determinations. The mean, SD and %CV were calculated for each pool as follows:
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The Direct Amylase assay yielded excellent between-run precision with CVs ≤ 2.0%.
2
Koll 843
510(k) PREMARKET NOTIFICATION
Direct Amylase Reagent
June 11, 2001
Interference Studies
The effects of interfering substances was evaluated by adding varying levels of potential interferents to a specimen pool. These determined that lipemia, triglyceride, ascorbic acid, bilirubin, hemoglobin and glucose did not interfere with the performance of the Genzyme Direct Amylase assay at the levels up to and including those indicated below.
| Interfering Substance | Concentration |
|---|---|
| Liposyn | 3000 mg/dL (1%) |
| Triglyceride | 3000 mg/dL |
| Ascorbic Acid | 50 mg/dL |
| Bilirubin (unconjugated) | 50 mg/dL |
| Bilirubin (conjugated) | 50 mg/dL |
| Hemoglobin | 500 mg/dL |
| Glucose | 2000 mg/dL |
Conclusion
Based on the results of the studies described above, the Genzyme Direct Amylase Reagent assay is substantially equivalent in performance to the predicate method for quantifying a-amylase activity in serum and plasma.
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.
3
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 curved lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 1 0 2001
Ms. Barbara Pizza Manager, Regulatory Affairs Genzyme Corporation One Kendall Square Cambridge, MA 02139-1562
510(k) Number: K011843 Re: Trade/Device Name: Direct Amylase Reagent Regulation Number: 862.1070 Regulatory Class: Class II Product Code: JFJ Dated: June 11, 2001 Received: June 12, 2001
Dear Ms. Pizza:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have leviewed your boomer of substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device interslate commerce pror to that have been reclassified in accordance with the provisions of the Ameliuments, of to devices and in . C (Act). You may, therefore, market the device, subject to rederal rood, Drug, and Cooment Fron et. The general controls provisions of the Act include the general controls pro risens of as 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 (Fremarks) Approval), it they of bacyeer Code of Federal Regulations, Title 21, Parts 800 to 895. allecting your device can of rounder assumes compliance with the Good Manufacturing A Substantally oquiratelly assisteneral (GMP) regulation (21 CFR Part 820) and that, through I ractive for Meansal bons, the Food and Drug Administration (FDA) will verify such perious offirmspoolis, are room the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal adultion, I DA may puonshilation and over premarket notification submission does not affect Register. Thease note: this respense to your 542 of the Act for devices under the ally oongation you inight in Control provisions, or other Federal laws or regulations.
4
Page 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 i 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrb/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
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
5
INTENDED USE 3.0
Page _ 1_of __ 1
Kolli843 510(k) Number (if known): __
Device Name: __ Direct Amylase Reagent
Intended Use:
For the quantitative determination of α-Amylase activity in human serum or plasma.
NOTE: This is not changed from the original Premarket submission K933397.
Indications for Use:
Levels of serum and plasma α-amylase in patients have provided needed evidence for the diagnosis of acute pancreatitis.
For In Vitro Diagnostic Use.
NOTE: This is not changed from the original Premarket submission K933397.
Cun Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K011843
(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)