(86 days)
For quality control in the quantitative determination of substrates, electrolytes, lipids, enzymes, proteins, and drugs. The control is used for monitoring accuracy or precision for manual techniques and assays from Roche on automated clinical chemistry analyzers.
Roche Diagnostics Precinorm® Universal and Precipath® Universal Control Sera is a two level quality control product prepared from lyophilized human serum with addition of constituent analytes as required to obtain normal and pathological levels.
The provided 510(k) summary for "Precinorm® Universal and Precipath® Universal Control Sera" describes a quality control product for laboratory assays. However, it does not include detailed acceptance criteria or a specific study proving the device meets those criteria in the way typically expected for a diagnostic or AI-driven medical device.
Instead, the submission focuses on establishing substantial equivalence to an already marketed predicate device (K811832). This means the primary "study" presented is a comparison to demonstrate that the modified device performs similarly to the predicate, with the main modification being the inclusion of additional analytes.
Therefore, many of the requested points cannot be directly extracted from the provided text because they pertain to a different type of device evaluation (e.g., performance study for a diagnostic algorithm, clinical trial for a treatment).
Here's a breakdown based on the provided information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide a table of acceptance criteria with specific numerical targets. Instead, it relies on demonstrating equivalence to a predicate device. The performance is implied to be similar to the predicate device, which is an already marketed and cleared product.
| Characteristic | Predicate Device (K811832) | Modified Device (K992900) | Equivalence Claim |
|---|---|---|---|
| Intended Use | For control of chemistry assays. Well suited for manual and automated analytical procedures. | For quality control in the quantitative determination of substrates, electrolytes, lipids, enzymes, proteins, and drugs. Used for monitoring accuracy or precision for manual techniques and assays from Roche on automated clinical chemistry analyzers. | Substantially equivalent in purpose. |
| Format | Lyophilized pooled human serum with constituents added as required to obtain desired component levels. | Lyophilized pooled human sera with constituents added as required to obtain desired component levels. | Identical. |
| Levels | Two levels | Two levels | Identical. |
| Stability (Unreconstituted) | Stable at 2-8° C until expiration date | Stable at 2-8° C until expiration date | Identical. |
| Stability (Reconstituted, 2-8° C) | 2 days | 5 days | Improved. |
| Stability (Reconstituted, 25° C / 10-24° C) | 8 hrs (at 10-24° C) | 12 hrs (at 25° C) | Improved. |
| Stability (Reconstituted, -20° C) | 1 month, with exceptions | 1 month, with exceptions | Identical. |
| Analytes | Standard analytes (not explicitly listed in this excerpt but implied by original clearance) | Standard analytes + Additional analytes (Albumin, Gamma globulins, Copper, GLDH, Arylamidase, Lithium, Magnesium, Total iron binding capacity) | Modified device adds analytes. Performance for these new analytes is not detailed but assumed to be adequate for quality control as per the overall substantial equivalence claim. |
The "acceptance criteria" here are essentially "performs sufficiently well as a quality control material for the listed analytes on clinical chemistry analyzers, similar to the predicate device, and includes values for additional analytes." There are no specific performance metrics like sensitivity, specificity, or AUC as one might see for an AI diagnostic.
2. Sample Size Used for the Test Set and Data Provenance:
This information is not provided. The submission is a regulatory filing for a quality control product, not a performance study for a diagnostic. The "test set" would implicitly be the demonstration that the control material can be used to monitor accuracy and precision on various analyzers, but no specific data or sample sizes for this demonstration are detailed.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. For a quality control material, "ground truth" would be the known concentration of analytes within the control serum, established through validated reference methods and internal quality assurance processes by the manufacturer. This isn't a diagnostic device requiring expert interpretation of patient data.
4. Adjudication Method for the Test Set:
Not applicable for a quality control material.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No. This is a quality control product, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical control serum, not an algorithm.
7. The Type of Ground Truth Used:
For a quality control material, the "ground truth" for the assigned values of the analytes within the sera is established by the manufacturer through rigorous analytical testing using reference methods and internal standardization processes. This is implicit in the manufacturing of such products.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/machine learning device that requires a training set. The "training" for such a product involves its manufacturing process and validation of its stability and assigned values.
9. How the Ground Truth for the Training Set was Established:
Not applicable. This is not an AI/machine learning device. The "ground truth" for its inherent properties (analyte concentrations, stability) would be established through a manufacturer's internal quality control and validation procedures based on analytical chemistry principles.
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510(k) Summary – Precinorm® Universal and Precipath® Universal Control Sera
| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. | |
|---|---|---|
| Submitter name, address, contact | Roche Diagnostics Corporation9115 Hague RdIndianapolis IN 46250(317) 576 3723 | |
| Contact person: Priscilla A. Hamill | ||
| Date prepared: August 25, 1999 | ||
| Predicate device | Roche Diagnostics Precinorm® Universal and Precipath® Universal Control Sera is substantially equivalent to other devices legally marketed in the United States. We claim equivalence to the currently marketed Roche Diagnostics Precinorm® Universal and Precipath® Universal Contrail Sera (K811832) | |
| Device description | Roche Diagnostics Precinorm® Universal and Precipath® Universal Control Sera is a two level quality control product prepared from lyophilized human serum with addition of constituent analytes as required to obtain normal and pathological levels. |
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510(k) Summary -- Precinorm® Universal and Precipath® Universal Control Sera, continued
| Intended use /Indication foruse | Roche Diagnostics Precinorm® Universal and Precipath® Universal ControlSera is intended for quality control in the quantitative determination ofsubstrates, electrolytes, lipids, enzymes, proteins, and drugs. The control isused for monitoring accuracy or precision for manual techniques and assaysfrom Roche on automated clinical chemistry analyzers. |
|---|---|
| Substantialequivalence | Precinorm® Universal and Precipath® Universal Control Sera are equivalentto other devices legally marketed in the United States. We claim equivalenceto the currently marketed Roche Diagnostics Precinorm® Universal andPrecipath® Universal Human Serum Controls cleared under documentK811832.The most important modification of the device presented in this submission isthe inclusion of values for additional analytes. Similarities and differencesare presented in detail below. |
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510(k) Summary – Precinorm® Universal and Precipath® Universal Control Sera, continued
Substantial equivalence similarities
The following table compares Precinorm® Universal and Precipath® Universal Human Serum Controls, with the predicate device (currently marketed modified Precinorm® Universal and Precipath® Universal Human Serum Controls.
| Characteristic | Precinorm® Universal andPrecipath® UniversalControl Sera(Modified Device) | Precinorm® Universal andPrecipath® UniversalHuman Serum Controls(Predicate Device) |
|---|---|---|
| Intended Use | For quality control in thequantitative determination ofsubstrates, electrolytes, lipids,enzymes, proteins, and drugs.The control is used formonitoring accuracy orprecision for manualtechniques and assays fromRoche on automated clinicalchemistry analyzers. | For control of chemistryassays. This control materialis well suited for both manualand automated analyticalprocedures. |
| Format | Lyophilized pooled humansera with constituents addedas required to obtain desiredcomponent levels | Lyophilized pooled humanserum with constituents addedas required to obtain desiredcomponent levels |
| Levels | Two levels | Two levels |
| Stability | • Stable at 2-8° C untilexpiration date• Reconstituted:✓ 2-8° C - 5 days✓ 25° - 12 hrs✓ -20° - 1 month, withexceptions as noted inlabeling | • Stable at 2-8° C untilexpiration date• Reconstituted:✓ 2-8° C - 2 days✓ 10-24° - 8 hrs✓ -20° - 1 month, withexceptions as noted inlabeling |
Comparison of Modified Device and Predicate Device
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510(k) Summary – Precinorm® Universal and Precipath® Universal Control Sera, continued
Substantial equivalence differences
The predicate device has been modified to include the additional analytes listed below.
| Additional analytes |
|---|
| Albumin |
| Gamma globulins |
| Copper |
| GLDH |
| Arylamidase |
| Lithium |
| Magnesium |
| Total iron binding capacity |
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Image /page/4/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 stripes forming its wing. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" surrounding it.
NOV 2 4 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Priscilla A. Hamill Regulatory Affairs, Laboratory Systems Roche Diagnostics Corporation 9115 Hague Road Indianapolis, Indiana 46250-0457
K992900 Re: Trade Name: Precinorm® Universal and Precipath® Universal Control Sera Regulatory Class: I Product Code: JJY Dated: August 25, 1999 Received: August 30, 1999
Dear Ms. Hamill:
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 (OS) 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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/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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INDICATIONS FOR USE STATEMENT
K992900 510(k) Number (if known): N/A
Device Name: Precinorm® Universal and Precipath® Universal Control Sera
Indications For Use:
For quality control in the quantitative determination of substrates, electrolytes, lipids, enzymes, proteins, i or quality control is used for monitoring accuracy or precision both for manual techniques and assays from Roche on automated clinical chemistry analyzers.
(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) |
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K99290
§ 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.