(24 days)
Intended for the in vitro quantitative determination of total Homocysteine in serum and plasma to assist in the diagnosis and treatment of patients suspected in having homocystinuria and hyperhomocysteinemia.
The Liquid Stable (LS) 2-Part Homocysteine Reagent will consist of two (2) reagents plus calibrators. The first reagent (LS-R1) will include Lactic Acid Dehydrogenase (LDH), Serine, and ß-Nicotinamide Adenine Di-Nucleotide reduced Di-Sodium Salt (NADH) with buffers and stabilizers. The fill volume will be 30 to 50 mL, depending on the kit configuration. The second reagent (LS-R2) will include Cystathionine B-Synthase (CBS) and Cystathionine B-Lyase (CBL) enzymes with buffers and stabilizers. The fill volume will be 7 mL for all kit configurations. The calibrators will include two (2) bottles; Calibrator "A" will be 0 µmoles/L and Calibrator "D" will be 25-30 umoles/L. The fill volume for the calibrators will be 3 mL.
This document is a 510(k) Special Premarket Notification for the Liquid Stable (LS) 2-Part Homocysteine Reagent. It details the device's characteristics and compares it to a legally marketed predicate device to establish substantial equivalence.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the comparison to the predicate device, K011689 Homocysteine Enzymic Homocysteine Reagent. The new device is considered to meet acceptance criteria if its performance is "Same" or comparable to the predicate device, especially for the "Correlation coefficient" and "Precision".
| Performance Metric | Acceptance Criteria (Predicate K011689) | Reported Device Performance (Liquid Stable (LS) 2-Part Homocysteine Reagent) |
|---|---|---|
| Correlation coefficient (compared to Abbott FPIA assay for predicate) | >0.95 (0.993) | >0.95 (0.997) (compared to current Homocysteine Enzymic Homocysteine Reagent) |
| Precision (within run) | ||
| Low | CV 3.5% | CV 2.3% |
| Mid | CV 2.5% | CV 1.8% |
| High | CV 2.1% | CV 1.3% |
| Precision (total) | ||
| Low | CV 5.6% | CV 4.3% |
| Mid | CV 4.7% | CV 2.8% |
| High | CV 3.8% | CV 2.4% |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It refers to performance data obtained when compared to other reagents, but the details of the samples used for these comparisons are not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The study focuses on comparing the new reagent's analytical performance against a predicate device, not on diagnostic interpretations requiring expert ground truth in the typical clinical sense.
4. Adjudication method for the test set
This information is not applicable and therefore not provided, as the study is an analytical performance comparison of a diagnostic reagent, not a clinical study involving human readers or interpretations.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC comparative effectiveness study was not done. This document describes an analytical performance evaluation of an in vitro diagnostic reagent, not an AI-assisted diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not directly applicable to the described device. The device is a chemical reagent, not an algorithm. The "standalone" performance is effectively the reported correlation coefficient and precision data, which are laboratory measurements of the reagent's analytical accuracy and reproducibility.
7. The type of ground truth used
The "ground truth" for this type of analytical validation is implicitly the performance of the established comparison methods:
- The "current Homocysteine Enzymic Homocysteine Reagent" for the correlation study.
- The Abbott FPIA assay (for the predicate device's correlation, which the new device aims to match or exceed).
The measurements obtained from these established methods are considered the reference or "ground truth" against which the new reagent's performance is assessed.
8. The sample size for the training set
This information is not applicable. The device is a chemical reagent, which does not involve a "training set" in the context of machine learning or AI algorithms.
9. How the ground truth for the training set was established
This information is not applicable, as there is no "training set" for this type of device.
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Image /page/0/Picture/0 description: The image shows a logo with a stylized letter 'C' above the word 'CATCH'. The 'C' is designed as a three-dimensional, curved shape, giving it a modern and abstract appearance. The word 'CATCH' is written in a bold, sans-serif font, positioned directly below the 'C' symbol. The overall design is simple yet eye-catching, with a clear emphasis on the brand name.
Kob 2808
007 1 3 2006
Special 510(k) Summary
| 510(k)'s Owner Name: | Catch Incorporated |
|---|---|
| Address: | 11822 Northcreek Parkway North, Suite 107Bothell, WA 98011 |
| Phone Number: | 425.402.8960 |
| Fax Number: | 425.402.8954 |
| Contact Person: | Glenn Kawasaki |
| Date of Preparation: | September 15, 2006 |
| Trade Name: | Liquid Stable (LS) 2-Part Homocysteine Reagent |
| Common Name: | Homocysteine Reagent |
Common Name: Classification Name:
Homocysteine Reage Urinary Homocystine (Nonquantitative) Test System
Device Description:
The Liquid Stable (LS) 2-Part Homocysteine Reagent will consist of two (2) reagents plus calibrators. The first reagent (LS-R1) will include Lactic Acid Dehydrogenase (LDH), Serine, and ß-Nicotinamide Adenine Di-Nucleotide reduced Di-Sodium Salt (NADH) with buffers and stabilizers. The fill volume will be 30 to 50 mL, depending on the kit configuration.
The second reagent (LS-R2) will include Cystathionine B-Synthase (CBS) and Cystathionine B-Lyase (CBL) enzymes with buffers and stabilizers. The fill volume will be 7 mL for all kit configurations.
The calibrators will include two (2) bottles; Calibrator "A" will be 0 µmoles/L and Calibrator "D" will be 25-30 umoles/L. The fill volume for the calibrators will be 3 mL.
Intended Use:
Intended for the in vitro quantitative determination of total homocysteine in serum and plasma.
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Kc62808
Summary of Technological Characteristics:
| Liquid Stable (LS)2-Part HomocysteineReagent | Homocysteine EnzymicHomocysteine ReagentK011689 | Comparison | |
|---|---|---|---|
| Intended Use | Intended for the in vitroquantitative determinationof total homocysteine inserum and plasma. | Intended for the in vitroquantitative determinationof total homocysteine inserum and plasma. | Same |
| Methodology | Clinical enzymaticchemistry reagents;2-part reagent | Clinical enzymaticchemistry reagents;2-part reagent | Same |
| Specimentype | Serum and plasma | Serum and plasma | Same |
| Instrumentation | Standard clinical chemistryanalyzer | Standard clinicalchemistry analyzer | Same |
| Calibration | Calibrator provided(0 µmoles/L and 25-30µmoles/L) | Calibrator provided(0 µmoles/L and 25-30µmoles/L) | Same |
| ReagentFormulations | Reagent LS R1 | R1A, R1B | Different |
| Reagent LS R2 | R2 | Same | |
| Calibrators | Calibrators | Same | |
| Performance | Correlation coefficient>0.95 (0.997) whencompared to currentHomocysteine EnzymicHomocysteine Reagent | Correlation coefficient>0.95 (0.993) whencompared to Abbott FPIAassay | Same |
| Precision(within run) | Low - CV 2.3% | Low - CV 3.5% | Same |
| Mid - CV 1.8% | Mid - CV 2.5% | ||
| High - CV 1.3% | High - CV 2.1% | ||
| Precision(total) | Low - CV 4.3% | Low - CV 5.6% | Same |
| Mid - CV 2.8% | Mid - CV 4.7% | ||
| High - CV 2.4% | High - CV 3.8% |
Similarities include: Intended use, methodology, specimen type, calibration requirements, and performance. Differences include: Modification of formulation-to improve reagent stability of R1 as compared to when Reagent R1A is mixed with Reagent R1B to give R1 in the Homocysteine Enzymic Homocysteine Reagent.
Conclusion based on similarities and differences: Liquid Stable (LS) 2-Part Homocysteine Reagent is substantially equivalent to the Homocysteine Enzymic Homocysteine Reagent.
:
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Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Catch Incorporated c/o Cindy Green, RAC Northwest Regulatory Support P.O. Box 1277 Maple Valley, WA 98038
OCT 1 3 2006
Re: K062808
Trade/Device Name: Liquid Stable (LS) 2-Part Homocysteine Reagent Regulation Number: 21 CFR 862.1377 Regulation Name: Urinary homocystine (non-quantitative) test system Regulatory Class: Class II Product Code: LPS Dated: September 29, 2006 Received: October 3, 2006
Dear Mr. Kawasaki:
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 marked in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendmonts, 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, isting 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 Degister.
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), and good mandated ing practi
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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,
Alberto Gutiérre
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
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Indications for Use
510(k) Number (if known): K062808
Device Name: Liquid Stable (LS) 2-Part Homocysteine Reagent
Indications For Use:
Intended for the in vitro quantitative determination of total Homocysteine in serum and plasma to assist in the diagnosis and treatment of patients suspected in having homocystinuria and hyperhomocysteinemia.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
Division Sign-Off
Office of In Vitro Diagnostic
Device Evaluation and Safety
51004 K062808
§ 862.1377 Urinary homocystine (nonquantitative) test system.
(a)
Identification. A urinary homocystine (nonquantitative) test system is a device intended to identify homocystine (an analogue of the amino acid cystine) in urine. The identification of urinary homocystine is used in the diagnosis and treatment of homocystinuria (homosystine in urine), a heritable metabolic disorder which may cause mental retardation.(b)
Classification. Class II.