(51 days)
The Wako L-type Amylase test is an in vitro diagnostic assay for the quantitative determination of amylase activity in serum. Determination of a-amylase activity is largely of use in the diagnosis of pancreatic diseases, but is also of value in detecting nonpancreatic disorders such as renal insufficiency, salivary gland lesions, macroamylasemia, and intra-abdominal diseases.
The Wako L-type Amylase is a kinetic assay employing a defined-substrate, p-nitrophenzy-a-maltopentaoside (BG5P), with glucoamylase and a-glucosidase as coupling enzymes. When a sample is allowed to react with the BG5P, BG3 and p-nitrophenyl-a-maltoside (PNP-G2) are formed by the action of a-amylase in the sample. The PNP-G2 produced is hydrolyzed to p-nitrophenol by the reactions of glucoamylase and a-glucosidase. By measuring the increase in absorbance of p-nirophenol at the optimum wavelength of 405 nm, a - amylase activity in the sample is determined.
The provided text describes the Wako L-type Amylase test, an in vitro diagnostic assay for determining amylase activity in serum. The submission focuses on establishing substantial equivalency to a predicate device, the Sigma Amylse test, rather than setting specific acceptance criteria for performance metrics like sensitivity or specificity.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Substantial Equivalency | To be substantially equivalent to the legally marketed predicate device (Sigma Amylse test). | Demonstrated substantial equivalency to the Sigma Amylse test. |
| Precision | Acceptable values on a day-to-day basis. (Specific numerical criteria not provided) | Precision studies indicate acceptable values can be obtained on a day to day basis. |
| Minimum Detectable Level (MDL) | Not explicitly stated as an acceptance criterion, but a low MDL is generally desired. | Estimated to be 1.0 IU/L. |
| Linearity | Not explicitly stated as an acceptance criterion, but linearity over a clinically relevant range is desired. | Determined to be linear to 3000 IU/L. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set. It mentions "Precision studies" and "The Wako L-type Amylase assay had determined to be linear," but does not provide details on the number of samples or data points.
The data provenance is not specified. It is not clear if the data was retrospective or prospective, nor the country of origin.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not describe the use of experts to establish ground truth for this device. The evaluation method described is a comparison to a predicate device, not an assessment against an expert-derived ground truth for diagnostic accuracy.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
No adjudication method is mentioned, as the study does not involve expert review or consensus for establishing ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No MRMC study was done. This type of study is typically performed for imaging or qualitative diagnostic devices where human readers interpret results, and the goal is to assess improvements in reader performance with AI assistance. The Wako L-type Amylase test is a quantitative, automated assay.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The performance described (precision, MDL, linearity) is the standalone performance of the assay, as it's an automated in vitro diagnostic test without direct human interpretation of the assay's output for diagnosis. The "algorithm" in this context is the chemical reaction and measurement process.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this submission is implicitly the performance and results obtained from the predicate device, the Sigma Amylse test. The study's objective was to demonstrate substantial equivalency to this existing, legally marketed device, not to establish a new gold standard.
8. The Sample Size for the Training Set
The document does not mention a "training set." For an in vitro diagnostic assay, development and validation typically refer to optimization of reagents and protocols, followed by performance verification runs. The concept of a distinct "training set" is more common for machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
As no training set is described in the context of machine learning, there is no information on how its ground truth was established. For the development and verification of the assay's chemical and measurement process, the "ground truth" would have been established through standard analytical chemistry practices, including the use of reference materials, calibrators, and known-concentration samples to optimize the reaction and detection parameters. However, specific details are not provided in this 510(k) summary.
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1984184
JAN 1 3 1999
Wako Chemicals USA, Inc. 1600 Beltwood Road, Richmond, VA 23237 U.S.A.
510(k) Summary of Safety and Effectiveness
The Wako L-type Amylase test is an in vitro diagnostic assay for the quantitative determination of amylase activity in serum.
Amylase is one of the digesting enzymes secreted predominantly from pancreas and salivary gland, which hydrolyzes a- 1,4-bonds of both straight-chain polysaccharides such as amylose and branched polysaccharides such as amylopectin. Determination of aamylase activity is largely of use in the diagnosis of pancreatic diseases, but is also of value in detecting nonpancreatic disorders such as renal insufficiency, salivary gland lesions, macroamylasemia, and intra-abdominal diseases. There are several methods used for the determination of a-amylase activity such as amyloclastic, saccharogenic, and defined-substrate methods.2 The Wako L-type Amylase is a kinetic assay employing a defined-substrate, p-nitrophenzy-a-maltopentaoside (BG5P), with glucoamylase and a-glucosidase as coupling enzymes.
When a sample is allowed to react with the BG5P, BG3 and p-nitrophenyl-a-maltoside (PNP-G2) are formed by the action of a-amylase in the sample. The PNP-G2 produced is hydrolyzed to p-nitrophenol by the reactions of glucoamylase and a-glucosidase. By measuring the increase in absorbance of p-nirophenol at the optimum wavelength of 405 nm, a - amylase activity in the sample is determined. A benzyl group in the nonreducing end glucose residue of GBSP prevents the hydrolysis by the cooupling enzymes and, thus, keeps a low blank absorbance. In this method, one unit of BG5P hydrolyzed by aamylase converts to one p-nitrophenol molecule. Therefore, one unit of a-amylase can be defined stoichiometrically as the amount of enzyme that produces one micro mol of p nitrophenol per minute.3,4
The safety and effectiveness of the Wako L-type Amylase assay is demonstrated by its substantial equivalency to the Sigma Amylse test.
Precision studies indicate acceptable values can be obtained on a day to day basis. The minimum detectable level of this method is estimated to be 1.0 IU/L. The Wako L-type Amylase assay had determined to be linear to 3000 IU/L.
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510(k) Summary Wako L-type Amylase Page 2
References:
(
- Berk, J.E. and Fridhandler, L.: Ann. Intern. Med., 26, 235-264 (1980). 1.
- Burtis, C.A. and Ashwood, E.R .: Tietz Textbook of Clinical Chemistry, 20d ed., 2. Saunders, Philadelphia, 1994.
- Satomura, S., Sakata, Y., Omichi, K. and Ikenaka, T.: Clin. Chem. Acta, 174, 315-3. 324 (1988).
- Satomura, S., Iwata, T., Sakata, Y., Omichi, K. and Ikenaka, T .: Carbohydr. Res., 4. 176, 107-115 (1988).
Kim Hallum
Tonya Mallory, Senior Manager, Diagnostics January 12, 1999 Wako Chemicals USA, Inc. 1600 Bellwood Road Richmond, VA 23237
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Public Health Service
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JAN 1 3 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Tonya Mallory Senior Manager, Diagnostics Wako Chemicals USA, Inc. 1600 Bellwood Road Richmond, Virginia 23237
Re: K984184 Trade Name: Wako L-type Amylase Regulatory Class: II Product Code: JFJ Dated: November 16, 1998 Received: November 23, 1998
Dear Ms. Mallory:
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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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/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Autman
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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Page of
K9 841 84 NUMBER (IF KNOWN) : 510 (k) DEVICE NAME: INDICATIONS FOR USE:
fine activit ull suremen nota an ari used pan creat DF
Jean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number
(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)
§ 862.1070 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.