{
  "release_id": "c7fb95f1d15a7d13",
  "id": "maternal:draeger-jm-105",
  "owner": "maternal",
  "kind": "product",
  "slug": "draeger-jm-105",
  "name": "Draeger Jaundice Meter JM-105",
  "aliases": [
    "JM-105",
    "Jaundice Meter JM-105"
  ],
  "atlases": [
    "maternal"
  ],
  "summary_plain": "A skin meter that gives a digital reading of yellowness in a newborn, to help clinicians monitor jaundice. In the United States it is cleared as a prescription device for hospitals, clinics and doctors' offices, not for home use; in a physician's office it may only be used at the sternum site. Its readings should be confirmed by a blood test before treatment decisions.",
  "summary_technical": "FDA 510(k) K133175, decision 13 November 2014, product code MQM, regulation 21 CFR 862.1113 (bilirubin in the neonate test system), regulatory class I, reserved (clearance letter). Applicant: Draeger Medical Systems, Inc. The Indications for Use call it a non-invasive transcutaneous bilirubinometer that is not a standalone for diagnosing hyperbilirubinemia. The openFDA record lists device class 1 and decision code SESE (substantially equivalent).",
  "editorial_state": "draft",
  "last_substantive_edit": "2026-10-14",
  "last_evidence_check": null,
  "next_review_due": null,
  "identifiers": [
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      "value": "MQM",
      "normalized_value": "MQM",
      "match": "broad",
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      "from_source": false
    }
  ],
  "navigation": {
    "maternal": {
      "life-stage": [
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      ],
      "care-area": [
        "newborn-care"
      ]
    }
  },
  "payload": {
    "subtype": "device",
    "model_or_formulation": "Jaundice Meter JM-105, a non-invasive transcutaneous bilirubinometer",
    "version": "As cleared under 510(k) K133175 on 2014-11-13 (Draeger Medical Systems, Inc.). Later versions are not covered.",
    "intended_use_snapshots": [
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      "category": "regulatory",
      "statement": "FDA cleared the Draeger Jaundice Meter JM-105 under 510(k) K133175 on 13 November 2014 as a non-invasive transcutaneous bilirubinometer. It measures yellowness of the tissue under the skin in newborn infants and gives a digital reading that has been shown to correlate with serum bilirubin. It is meant to help clinicians monitor newborn infants in hospitals, clinics or doctors' offices, under a physician's supervision. It is not intended as a standalone for diagnosing high bilirubin: it is used with other clinical signs and laboratory measurements, and bilirubin levels should be confirmed by other methods, such as serum bilirubin, before treatment decisions. It is a prescription device and is not intended for home use. In a physician's office it may only be used at the sternum measurement site.",
      "context": {
        "id": "maternal:ctx-fda-k133175-newborns-us",
        "label": "Newborn infants measured with the Jaundice Meter JM-105 in US hospitals, clinics and doctors' offices",
        "recipient": "newborn",
        "population": "Newborn infants. The meter is a prescription device used under a physician's supervision; it is not intended for home use.",
        "care_setting": "Hospitals, clinics or doctors' offices, under physician supervision or direction.",
        "geography": "United States (FDA clearance)",
        "life_stage_note": "Newborn infants",
        "life_stage_terms": {
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        "gestational_age_min_days": null,
        "gestational_age_max_days": null,
        "gestational_age_basis": null,
        "postnatal_age_min_days": null,
        "postnatal_age_max_days": null,
        "gestational_age_status": null,
        "postnatal_age_status": null,
        "followup_description": "Not applicable: a device clearance, not a study.",
        "eligibility": {
          "inclusion": [
            "Newborn infants monitored by clinicians in hospitals, clinics or doctors' offices"
          ],
          "exclusion": [
            "Home use"
          ]
        }
      },
      "evidence_stage": "not_applicable",
      "certainty": "not_assessed",
      "certainty_method": null,
      "limitations": "The statement rests on the FDA clearance letter and Indications for Use form. A 510(k) clearance means FDA found the device substantially equivalent to a predicate device; it is not a finding of clinical benefit. The clearance is for the United States, and the regulatory class on the letter is I, reserved.",
      "editorial_state": "draft",
      "checked_at": null,
      "next_review_due": null,
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