(129 days)
Not Found
No
The document describes a quality control serum for immunoassay systems and does not mention AI or ML.
No
This device is a control serum used for quality control of immunoassay systems, not for treating or diagnosing patients.
No
Explanation: The device, PreciControl Bone, is a quality control product for immunoassays. Its purpose is to monitor the accuracy and precision of other diagnostic tests, not to directly diagnose a disease or condition in a patient.
No
The device description clearly states that PreciControl Bone contains lyophilized control serum, which is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "quality control of specified Elecsys immunoassays on Elecsys immunoassay systems." This means it's used in vitro (outside the body) to assess the performance of other diagnostic tests.
- Device Description: The description confirms it's a "lyophilized control serum" used for "monitoring the accuracy and precision" of specific immunoassays. This is a classic function of an IVD control material.
- Predicate Device: The mention of a predicate device (K993706; Elecsys® PreciControl Bone) further supports its classification as an IVD, as predicate devices are typically other legally marketed IVDs.
While the document doesn't contain information about image processing, AI, patient age, or performance studies (which are often associated with more complex IVDs), the core function and description clearly place it within the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
PreciControl Bone is used for quality control of specified Elecsys immunoassays on Elecsys immunoassay systems.
Product codes (comma separated list FDA assigned to the subject device)
JJY
Device Description
PreciControl Bone contains lyophilized control serum based on equine serum in three concentration ranges. The controls are used for monitoring the accuracy and precision of Elecsys β-CrossLaps/serum (β-CTX), N-MID Osteocalcin, and PTH (parathyroid hormone) immunoassays.
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
Not Found
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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001 17 2005
510(k) Summary - Elecsys® PreciControl Bone
| 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 Corporation |
| 9115 Hague Rd | |
| Indianapolis IN 46250 | |
| (317) 521-3831 |
Contact person: Corina Harper
Date prepared: Jun 9, 2005 |
| Device Name | Proprietary name: Elecsys® PreciControl Bone
Common name: Control
Classification name: Multi-analyte Controls (assayed and unassayed) |
| Device description | PreciControl Bone contains lyophilized control serum based on equine serum in three concentration ranges. The controls are used for monitoring the accuracy and precision of Elecsys β-CrossLaps/serum (β-CTX), N-MID Osteocalcin, and PTH (parathyroid hormone) immunoassays. |
| Intended use | PreciControl Bone is used for quality control of specified Elecsys immunoassays on Elecsys immunoassay systems. |
| Predicate Device | We claim substantial equivalence to the currently marketed Elecsys® PreciControl Bone (K993706). |
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510(k) Summary - Elecsys® PreciControl Bone, continued
Device Comparison The table below indicates the similarities between the modified Elecsys® PreciControl Bone and the current device.
| Topic | Current Elecsys® PreciControl
Bone
(approved via K993706) | Modified Elecsys® PreciControl
Bone
(Modified Device) |
|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | PreciControl Bone is used for quality control of the Elecsys β-
CrossLaps/serum (β-CTX) and PTH (parathyroid hormone) immunoassays on Elecsys 1010/2010 and MODULAR ANALYTICS E170 immunoassay systems. | PreciControl Bone is used for quality control of specified Elecsys immunoassays on Elecsys immunoassay systems. |
| Analyzer
System | Elecsys® immunoassay analyzers | Same |
| Reagent
Format | lyophilized, based on equine serum | Same |
| Analyte
Concentration
PCB1/PCB2/P
CB3 | β-CTX (synthetic): approx. 0.315, 0.75 & 3.0 ng/mL
PTH (synthetic): approx. 60, 205 & 850 pg/mL | β-CTX (synthetic): approx. 0.315, 0.75 & 3.0 ng/mL
PTH (synthetic): approx. 60, 205 & 850 pg/mL
Osteocalcin (synthetic): approx. 20, 100 & 205 ng/mL |
| Stability | @ 2-8° C
• unopened until expiration date
Reconstituted/thawed
@ 20-25° C
• 8 hours (in total)
@ 2-8° C
• 5 days
@ -20° C (four freeze/thaw cycles possible)
• 1 month | @ 2-8° C
• unopened until expiration date
Reconstituted/thawed
@ 20-25° C
• 8 hours (in total)
@ 2-8° C
• 5 days
@ -20° C (four freeze/thaw cycles possible)
• 1 month |
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with outstretched wings. The bird is facing to the right. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 17 2005
Ms. Corina Harper, RAC Regulatory Affairs Consultant Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250
Re: K051543
Trade/Device Name: Elecsys PreciControl Bone Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: September 13, 2005 Received: September 14, 2005
Dear Ms. Harper:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becternined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encroate) to regions and date of the Medical Device Amendments, or to commerce pror to May 2011/70, tie accordance with the provisions of the Federal Food, Drug, devices that have been require approval of a premarket approval application (PMA). and Cosmetic 71ct (71ct) that do not requently controls provisions of the Act. The r ou may, mererore, manel the Act include requirements for annual registration, listing of general controls provisions of wactice, 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 it may be subject its sach additions (CFR), Parts 800 to 895. In additions (CFR), Parts 800 to 895 can be found in The Broomcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I least be advised mat i Dri i issualite or our device complics with other requirements of the Act that 1197 has Intact a as a regulations administered by other Federal agencies. You must of any I caefar statutes and registments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice erre rant 007), lawelling systems (QS) regulation (21 CFR Part 820).
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Page 2 --
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,
Carol C. Benam
Carol C. Benson, M.A. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: Elecsys PreciControl Bone
Indications For Use:
PreciControl Bone is used for quality control of specified Elecsys immunoassays on Elecsys immunoassay systems.
Prescription Use XXX (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 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)
A.C.K.
Division/Sign-Off
Office of In Vitro Diagnostic Device Evaluation and safety
510(k) K501543
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